Interstitial Lung DiseaseO2LUSSUNCT05631756
Correlation Between PaO2/FiO2 and Lung Ultrasound Score in the Intensive Care Unit
A study testing Lung Ultrasound in people with Interstitial Lung Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial summary
The goal of this physiological interventional prospective study is to evaluate the improvement of the previously demonstrated correlation between PaO2/ FiO2 and Lung Ultrasound score (LUSS) in patients admitted in the ICU with an intesrtitial syndrom (IS) on the ultrasound of all aetiologies at inclusion and at twenty… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Lung Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesBelgium
- Study dates
- 26 Jan 2023to 13 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- consent
- ->17 years old
Who cannot join
- LUSS < 2
- Non Inclusion Criteria:
- Patient with pathologies leading to chronic IS
- Chronic Obstructive Pulmonary Disease (COPD) or active asthma
- Patients under veino-veinous or veino-arterial " Extracorporeal Membrane Oxygenation " (ECMO)
- Severe trauma patients
- Less than twenty-four hours post operative patients
- LUS not feasible: prone position, pneumonectomy history, severe obesity
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Cliniques universitaires saint luc
Brussels, Brussels Capital, 1200
Centres Hospitaliers de Jolimont
Haine-Saint-Paul, Hainaut, 7100
About this study
Official title: "Correlation Between PaO2/FiO2 and Lung Ultrasound Score in Patients Admitted to an Intensive Care Unit With Interstitial Syndrome: A Prospective Physiological Study"
The goal of this physiological interventional prospective study is to evaluate the improvement of the previously demonstrated correlation between PaO2/ FiO2 and Lung Ultrasound score (LUSS) in patients admitted in the ICU with an intesrtitial syndrom (IS) on the ultrasound of all aetiologies at inclusion and at twenty four and forty eight hours.
The main question it aims to answer is if the LUSS is a valid tool to evaluate the severity of the IS Participants will initially have an arterial blood gas to evaluate the PaO2/FiO2 and in the ten minutes a lung ultrasound to evaluate the LUSS. This will be repeated at twenty four and forty eight hours.
Read the detailed description
JUSTIFICATION FOR THE RESEARCH
Interstitial Syndrome (IS) also known as alveolar-interstitial syndrome, is a diffuse affection of the lung interstitial tissue leading to decreased alveolo-capillary exchange and therefore hypoxemia. Acute conditions such as viral or bacterial pneumonia and pulmonary edema lead to IS. Pulmonary edema can either be haemodynamically induced in acute heart failure (AHF) or secondary to permeability impairment in Acute Respiratory Distress Syndrome (ARDS). In literature, Acute Lung Injury (ALI) is also used to refer to a condition similar to ARDS with less severe hypoxemia. Chronic pathologies as Diffuse Parenchymal Lung Disease (DPLD) also cause IS. Lung Ultrasound (LUS) is a useful tool to diagnose IS. Indeed, LUS is non-invasive, non-irradiating, low cost and easily available at the patient's bedside. The interest of LUS for critically ill patient has been demonstrated5. In ICU, it was shown that LUS reduces number of chest radiography, relative medical costs and radiation exposure without affecting patient outcome. Literature suggests that LUS diagnostic accuracy for IS is higher than the diagnostic accuracy of chest radiography. Chest Computed Tomography is the actual gold standard for IS diagnosis, however not available at patient bedside, irradiating and more expensive. LUS is mostly based on the detection of artefacts created by air-tissue interfaces5. In IS, artefacts have been shown to be related to the presence of extra-vascular water and the water-thickened of interlobular septa. Comet Tail Artefact (CTA) was originally described as dense tapering trail of echoes just distal to a strongly reflective surface whereas Ring Down Artefact (RDA) starts from the point of origin of the ultrasound waves and "ring-down" to the end of the screen without fading. CTA and RDA are created by different mechanisms. Liechtenstein's early work introduced the term CTA to describe artefacts found in IS4. He later introduced the alphabetic nomenclature and assign the term B-lines to those IS artefacts. According to Yue Lee and All, a confusion between CTA and RDA exist in the literature as B-Lines definition correspond to RDA rater then CTA. International recommendations later agreed on the use of the term B-line, to describe artefact found in IS. Presence of multiple B-lines is widely recognised to suggest the presence of IS. Despite poor literature on this topic, IS severity is represented by hypoxemia generally evaluated by the realization of an Arterial Blood Gase (ABG) to obtain Arterial Partial Pressure in Oxygen (PaO2). A study however supported the absence of correlation between PaO2 and long-term mortality for AHF. Another rather recent study, including one-hundred and sixty-five COVID-19 patients that underwent non-invasive ventilation, nevertheless showed a statistically significant difference in PaO2 between survivor and non-survivor at twenty-eight days. According to the Berlin definition, hypoxemia represented by the ratio between PaO2 and the fraction of inspired oxygen (FiO2) is a severity indicator in ARDS. LUS could be an alternative to evaluate severity of IS. The Lung Ultrasound Score (LUSS) was initially developed on an experimental model to assess lung aeration and is based on quantitative assessment of B-lines in six thoracic zones bilaterally. In each zone, a sonographic lung aeration status is determined scoring from zero to four to determine a total score over thirty-six. Literature findings are consistent with LUSS being an efficient tool to measure lung aeration in different intensive care situations: re-aeration antibiotics-induced in Ventilator Associated Pneumonia, assessment of PEEP-induced lung recruitment. LUSS realized during weaning trial has been showed to be able to predict of postextubation distress. In the Intensive Care Unit (ICU), LUSS is efficient to quantify lesions and predict mortality associated with ARDS. During the recent COVID-19 pandemic, numerous trials have demonstrated that LUSS is associated with disease severity and mortality in COVID-19 patients. Recently, a negative linear correlation between PaO2/FiO2 and LUSS was shown three series of patients admitted to Intensive Care Units (ICU) with different aetiologies of IS: one with thirty-three COVID-19 patients, one with thirty-seven ARDS patients and one with seventy-two ALI patients. Lately, this correlation was confirmed in larger series of one-hundred and sixty-two patients admitted the Emergency Departement (ED) suggesting that LUSS could be a tool to evaluate PaO2 and therefore evaluate IS severity regardless of IS' aetiology in patients admitted to ED.
STUDY PROCEDURE
A LUSS will be realized by an investigator trained for Lung UltraSound (LUS) and considering him/herself confident for its use. A five-point Likert scale will be filled. To the statement "I am qualified to realize a LUSS", only emergency doctors answering "I strongly agree" or "I agree" will be eligible for inclusion and added to investigators list using an amendment to this protocol. The ultrasound machines operated for LUS belong to each ED meaning the investigators are familiar to its use. To uniformize the results, settings of the ultrasound machines will be standardized. To allow the exploration of the pulmonary parenchyma a low frequency curvilinear transducer will be used, and evaluation of B-lines will be performed using a depth of at least 12cm as commonly recommended. If patients are isolated for infectious reasons, special precautions will be applied following institutional procedures of ultrasound use on contagious patients. LUS will take place within 10 minutes of ABG analysis. LUS will be performed at the patient's bedside. The investigator will be blinded to any other procedure made by treating physician for diagnostic purposes. The treating physician will be allowed to perform a LUS on its own. The LUSS procedure will be used as validated in a larger number of studies. For that matter, the thorax is virtually divided in six thoracic zones bilaterally, comporting two anterior zones, two lateral zones and two posterior zones. The anterior and lateral zones will be evaluated in strict dorsal decubitus and the posterior zones will be evaluated with a light contro-lateral decubitus allowed, if necessary, because of patient morphotype.
For each zone a score from zero to three will be determined as shown in figure 4:
- 0: A normal aeration of the lung with presence of A lines, persistent pleural sliding and less than three B-lines.
- 1: Interstitial syndrome, resulting in moderate loss of aeration with more than three spaced B-lines, 7mm apart, scores one point.
- 2: Alveolar-interstitial syndrome meaning a severe loss of aeration with coalescent B-lines, less then 3mm apart, scores two.
- 3: An alveolar consolidation leading to a complete loss of aeration with an ultrasonographic tissue like pattern.
LUSS will be calculated by adding the score given to each 12 zones, with a maximum of thirty-six. Patients scoring less than two, will be considered empirically with no interstitial syndrome and will be excluded of the study.
Investigators will also report the presence of pleural effusions and if present estimate their amount. If present, pleural effusions quantification will be realized at lung base. The maximal distance between parietal and visceral pleura (Dmax) in millimeter will be measured after freezing the image in end-expiration.
If the ABG indication according to treating ICU physician persist, the complete intervention including calculation of LUSS, research and quantification of pleural effusions will be repeated at twenty-four and forty-eight hours.
Result of LUSS, pleural effusions' presence and Dmax won't be communicated to the treating physician expect if the LUS results could influence patient prognosis.
STUDY CONDUCTION
Study Settings:
Before the study launching, the investigator will be evaluated using a five-point Likert scale as previously described. A presentation of the study and the procedure will be organized by the coordinating investigators in each center.
Patients' recruitment:
The eligible patients will be identified by the treating ICU physician. Adult patients admitted to ICU with signs and symptoms of ARF and an indication of realization of ABG to evaluate PaO2 according to treating ICU physician will be considered for inclusion. ABG won't be considered as an intervention as the decision of the realization of an ABG is being left to the treating ICU physician. If those criteria are met, treating physician will contact an investigator.
Inclusion:
Investigator will be responsible to verify if patient meet all inclusion criteria. Consent will correspond to the signature of a paper consent form in duplicate after being informed over research modalities by the investigator. If the patient is unable to give his consent because of an acute condition and have no legal representative, a delayed consent will be authorized. One signed copy of the consent form will be returned to the patient or the legal representative.
Intervention:
All included patients will undergo a LUS, the calculation of a LUSS and search of pleural effusions and pleural effusions' quantification by Dmax measurement when pleural effusions are present. In Belgium, LUS isn't recognized as standard of care giving to this study an interventional character. Intervention will take place in a range of time of maximum then minutes before or after ABG realization. The result of the intervention will not be communicated to the treating physician except when LUS could influence patient's prognosis.
Follow up:
If ABG indication persists following treating ICU physician and if the patient is still present in the ICU, the intervention as described previously will be repeated at twenty-four and forty-eight hours.
Data collection and Data treatment:
After inclusion data will be reported in an informatized CRF using REDCap software by investigator and Pleural Effusion Volume (Vpe) in milliliter will be automatically calculated by multiplying Dmax per twenty according to Balik and all's formula. The SOFA score at inclusion, twenty-four and forty-eight hours will also be calculated and recorded. Name, first name, date of birth and hospital administrative number of the included patients will be recorded. Investigators will only access personal data of the patient they have personally included. Principal investigators will have access to all personal data to be able to collect missing data. After data completion, a neutral identifier composed by inclusion centre's number, number of inclusion and year of birth will be used. A correspondence list will be kept under the principal investigator responsibility.
STATISTICS
Data analysis was performed using JMP Pro 16.0.0 Software (SAS Institute). Continuous variables are expressed as mean values and standard deviations. Discrete variables are reported as categories and expressed as numbers and percentages. The Pearson correlation was used to measure the linear correlation between continuous variables, and correlations are expressed as correlation coefficient and 95% confidence interval. Comparisons between quantitative data were performed with a χ2 test, and between-group comparisons between continuous data with a Wilcoxon-Mann-Whitney test. The significance threshold was set with a P value of < 0.05. A one-sided hypothesis test will be use to show the improvement of the correlation between PaO2/FiO2 and LUSS. Pearson formula will be used to show correlation between PaO2/FiO2 and LUSS. Multiple linear regression will be used to test the effects of continuous variables such as presence of pleural effusions on the correlation between PaO2/FIO2 and LUSS.
- Conditions
- Interstitial Lung Disease
- Being tested
- Lung Ultrasound
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundOther
Evaluation of the Lung Ultrasound Score in patients presenting an interstitial syndrom on the lung ultrasound and to compare it with PaO2/FiO2
| Study group | Role | What they receive |
|---|---|---|
| Patient Population | Experimental | All patients included in the study, meaning patients in the ICU presenting an interstitial syndrom no matter the aetiology Receives: Other: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation PaO2/FiO2 and LUSS
To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS.
Measured: At inclusion
Secondary outcomes (29)
Evolution
To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS.
Measured: Twenty four and forty eight hours
Lung Ultrasound Score and SOFA score
to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS.
Measured: Inclusion,twenty four and forty eight hours
Influence SOFA on the correlation between PaO2/FiO2 and LUSS
To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS.
Measured: Inclusion,twenty four and forty eight hours
Pleural Effusions
To to determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS.
Measured: Inclusion, twenty four and forty eight hours
Correlation PaO2/FiO2 and the LUSS according to IS diagnosis
To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation)
The end point of this secondary outcome considers the null hypothesis to be an improvement of 0,214 of the correlation between PaO2/FiO2 and LUSS
Measured: Inclusion
Correlation between the PaO2/FiO2 and the LUSS admission diagnosis
To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS according to admission diagnosis (cardiogenic shock, sepsis, infection, post operative)
Measured: Inclusion
Correlation between the PaO2/FiO2 and the LUSS according to the LUSS value
To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) The end point of this secondary outcome considers a negative linear distribution for PaO2/FiO2 and LUSS values
Measured: Inclusion
Correlation between the PaO2/FiO2 and LUSS according to hypoxemia
To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS acordiing on hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred)
Measured: Inclusion
Correlation between the PaO2/FiO2 and LUSS according to the RR at admission
To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty)
Measured: Inclusion
Evolution of the correlation between the PaO2/FiO2 and the LUSS according to IS diagnosis
To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation) a negative linear distribution for PaO2/FiO2 and LUSS values
Measured: Twenty four and forty eight hours
Evolution of the correlation between the PaO2/FiO2 and the LUSS according to admission diagnosis
To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS according to admission diagnosis (cardiogenic shock, sepsis, infection, post operative)
Measured: Twenty four and forty eight hours
Evolution of the correlation between the PaO2/FiO2 and the LUSS according to LUSS value
To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS according to LUSS value (between two and six and between seven and thirty-six)
Measured: Twenty four and forty eight hours
Evolution of the correlation between the PaO2/FiO2 and the LUSS according to hypoxemia severity
To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS acordiing on hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred)
Measured: Twenty four and forty eight hours
Evolution of the correlation between the PaO2/FiO2 and the LUSS according RR
To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty)
Measured: Twenty four and forty eight hours
Correlation between LUSS and the SOFA score at inclusion according to the diagnosis of the IS
To assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Correlation between LUSS and the SOFA score at inclusion according to admission diagnosis
to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS according to admission diagnosis (cardiogenic shock, sepsis, infection, post operative) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Correlation between LUSS and the SOFA score according to the LUSS value
to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Correlation between LUSS and the SOFA score according to hypoxemia severity
to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS acordiing on hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Correlation between LUSS and the SOFA score according to the RR
to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to IS diagnosis
To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to admission diagnosis
To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with ISaccording to admission diagnosis (cardiogenic shock, sepsis, infection, post operative) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to LUSS value
To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to hypoxemia severity
To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS acordiing on hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to RR
To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS.according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score
Measured: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to IS diagnosis
To determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation) The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size.
Measured: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to admission diagnosis
To determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS according to admission diagnosis (cardiogenic shock, sepsis, infection, post operative) The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size.
Measured: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to LUSS value
To determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size.
Measured: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to hypoxemia severity
To determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS acordiing to hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred) The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size.
Measured: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to RR
To the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty)
The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size.
Measured: Inclusion,twenty four and forty eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start26 Jan 2023
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleonore Vasseur, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631756
- Sponsor's protocol ID
- 2022/24NOV/444
- Acronym
- O2LUSSU
- Status last verified
- Apr 2026
- First submitted
- 13 Oct 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
PubMed 16984837Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
PubMed 22392031ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.
PubMed 9372688Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.
PubMed 30372119Zieleskiewicz L, Cornesse A, Hammad E, Haddam M, Brun C, Vigne C, Meyssignac B, Remacle A, Chaumoitre K, Antonini F, Martin C, Leone M. Implementation of lung ultrasound in polyvalent intensive care unit: Impact on irradiation and medical cost. Anaesth Crit Care Pain Med. 2015 Feb;34(1):41-4. doi: 10.1016/j.accpm.2015.01.002. Epub 2015 Mar 5.
PubMed 25829314Brogi E, Bignami E, Sidoti A, Shawar M, Gargani L, Vetrugno L, Volpicelli G, Forfori F. Could the use of bedside lung ultrasound reduce the number of chest x-rays in the intensive care unit? Cardiovasc Ultrasound. 2017 Sep 13;15(1):23. doi: 10.1186/s12947-017-0113-8.
PubMed 28903756Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006.
PubMed 14695718Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. doi: 10.1378/chest.127.5.1690.
PubMed 15888847Soldati G, Copetti R, Sher S. Sonographic interstitial syndrome: the sound of lung water. J Ultrasound Med. 2009 Feb;28(2):163-74. doi: 10.7863/jum.2009.28.2.163.
PubMed 19168766Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70. doi: 10.1016/j.amjcard.2004.02.012.
PubMed 15135701Ziskin MC, Thickman DI, Goldenberg NJ, Lapayowker MS, Becker JM. The comet tail artifact. J Ultrasound Med. 1982 Jan-Feb;1(1):1-7. doi: 10.7863/jum.1982.1.1.1.
PubMed 6152918Yue Lee FC, Jenssen C, Dietrich CF. A common misunderstanding in lung ultrasound: the comet tail artefact. Med Ultrason. 2018 Aug 30;20(3):379-384. doi: 10.11152/mu-1573.
PubMed 30167593Minana G, Nunez J, Banuls P, Sanchis J, Nunez E, Robles R, Mascarell B, Palau P, Chorro FJ, Llacer A. Prognostic implications of arterial blood gases in acute decompensated heart failure. Eur J Intern Med. 2011 Oct;22(5):489-94. doi: 10.1016/j.ejim.2011.01.014. Epub 2011 Feb 25.
PubMed 21925058Gupta B, Jain G, Chandrakar S, Gupta N, Agarwal A. Arterial Blood Gas as a Predictor of Mortality in COVID Pneumonia Patients Initiated on Noninvasive Mechanical Ventilation: A Retrospective Analysis. Indian J Crit Care Med. 2021 Aug;25(8):866-871. doi: 10.5005/jp-journals-10071-23917.
PubMed 34733025
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Correlation Between PaO2/FiO2 and Lung Ultrasound Score in Patients Admitted to an Intensive Care Unit With Interstitial Syndrome: A Prospective Physiological Study"
- ClinicalTrials.gov ID
- NCT05631756
- Acronym / sponsor ID
- O2LUSSU / 2022/24NOV/444
- Conditions
- Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this physiological interventional prospective study is to evaluate the improvement of the previously demonstrated correlation between PaO2/ FiO2 and Lung Ultrasound score (LUSS) in patients admitted in the ICU with an intesrtitial syndrom (IS) on the ultrasound of all aetiologies at inclusion and at twenty four and forty eight hours.
The main question it aims to answer is if the LUSS is a valid tool to evaluate the severity of the IS Participants will initially have an arterial blood gas to evaluate the PaO2/FiO2 and in the ten minutes a lung ultrasound to evaluate the LUSS. This will be repeated at twenty four and forty eight hours.
Detailed description
JUSTIFICATION FOR THE RESEARCH
Interstitial Syndrome (IS) also known as alveolar-interstitial syndrome, is a diffuse affection of the lung interstitial tissue leading to decreased alveolo-capillary exchange and therefore hypoxemia. Acute conditions such as viral or bacterial pneumonia and pulmonary edema lead to IS. Pulmonary edema can either be haemodynamically induced in acute heart failure (AHF) or secondary to permeability impairment in Acute Respiratory Distress Syndrome (ARDS). In literature, Acute Lung Injury (ALI) is also used to refer to a condition similar to ARDS with less severe hypoxemia. Chronic pathologies as Diffuse Parenchymal Lung Disease (DPLD) also cause IS. Lung Ultrasound (LUS) is a useful tool to diagnose IS. Indeed, LUS is non-invasive, non-irradiating, low cost and easily available at the patient's bedside. The interest of LUS for critically ill patient has been demonstrated5. In ICU, it was shown that LUS reduces number of chest radiography, relative medical costs and radiation exposure without affecting patient outcome. Literature suggests that LUS diagnostic accuracy for IS is higher than the diagnostic accuracy of chest radiography. Chest Computed Tomography is the actual gold standard for IS diagnosis, however not available at patient bedside, irradiating and more expensive. LUS is mostly based on the detection of artefacts created by air-tissue interfaces5. In IS, artefacts have been shown to be related to the presence of extra-vascular water and the water-thickened of interlobular septa. Comet Tail Artefact (CTA) was originally described as dense tapering trail of echoes just distal to a strongly reflective surface whereas Ring Down Artefact (RDA) starts from the point of origin of the ultrasound waves and "ring-down" to the end of the screen without fading. CTA and RDA are created by different mechanisms. Liechtenstein's early work introduced the term CTA to describe artefacts found in IS4. He later introduced the alphabetic nomenclature and assign the term B-lines to those IS artefacts. According to Yue Lee and All, a confusion between CTA and RDA exist in the literature as B-Lines definition correspond to RDA rater then CTA. International recommendations later agreed on the use of the term B-line, to describe artefact found in IS. Presence of multiple B-lines is widely recognised to suggest the presence of IS. Despite poor literature on this topic, IS severity is represented by hypoxemia generally evaluated by the realization of an Arterial Blood Gase (ABG) to obtain Arterial Partial Pressure in Oxygen (PaO2). A study however supported the absence of correlation between PaO2 and long-term mortality for AHF. Another rather recent study, including one-hundred and sixty-five COVID-19 patients that underwent non-invasive ventilation, nevertheless showed a statistically significant difference in PaO2 between survivor and non-survivor at twenty-eight days. According to the Berlin definition, hypoxemia represented by the ratio between PaO2 and the fraction of inspired oxygen (FiO2) is a severity indicator in ARDS. LUS could be an alternative to evaluate severity of IS. The Lung Ultrasound Score (LUSS) was initially developed on an experimental model to assess lung aeration and is based on quantitative assessment of B-lines in six thoracic zones bilaterally. In each zone, a sonographic lung aeration status is determined scoring from zero to four to determine a total score over thirty-six. Literature findings are consistent with LUSS being an efficient tool to measure lung aeration in different intensive care situations: re-aeration antibiotics-induced in Ventilator Associated Pneumonia, assessment of PEEP-induced lung recruitment. LUSS realized during weaning trial has been showed to be able to predict of postextubation distress. In the Intensive Care Unit (ICU), LUSS is efficient to quantify lesions and predict mortality associated with ARDS. During the recent COVID-19 pandemic, numerous trials have demonstrated that LUSS is associated with disease severity and mortality in COVID-19 patients. Recently, a negative linear correlation between PaO2/FiO2 and LUSS was shown three series of patients admitted to Intensive Care Units (ICU) with different aetiologies of IS: one with thirty-three COVID-19 patients, one with thirty-seven ARDS patients and one with seventy-two ALI patients. Lately, this correlation was confirmed in larger series of one-hundred and sixty-two patients admitted the Emergency Departement (ED) suggesting that LUSS could be a tool to evaluate PaO2 and therefore evaluate IS severity regardless of IS' aetiology in patients admitted to ED.
STUDY PROCEDURE
A LUSS will be realized by an investigator trained for Lung UltraSound (LUS) and considering him/herself confident for its use. A five-point Likert scale will be filled. To the statement "I am qualified to realize a LUSS", only emergency doctors answering "I strongly agree" or "I agree" will be eligible for inclusion and added to investigators list using an amendment to this protocol. The ultrasound machines operated for LUS belong to each ED meaning the investigators are familiar to its use. To uniformize the results, settings of the ultrasound machines will be standardized. To allow the exploration of the pulmonary parenchyma a low frequency curvilinear transducer will be used, and evaluation of B-lines will be performed using a depth of at least 12cm as commonly recommended. If patients are isolated for infectious reasons, special precautions will be applied following institutional procedures of ultrasound use on contagious patients. LUS will take place within 10 minutes of ABG analysis. LUS will be performed at the patient's bedside. The investigator will be blinded to any other procedure made by treating physician for diagnostic purposes. The treating physician will be allowed to perform a LUS on its own. The LUSS procedure will be used as validated in a larger number of studies. For that matter, the thorax is virtually divided in six thoracic zones bilaterally, comporting two anterior zones, two lateral zones and two posterior zones. The anterior and lateral zones will be evaluated in strict dorsal decubitus and the posterior zones will be evaluated with a light contro-lateral decubitus allowed, if necessary, because of patient morphotype.
For each zone a score from zero to three will be determined as shown in figure 4:
- 0: A normal aeration of the lung with presence of A lines, persistent pleural sliding and less than three B-lines.
- 1: Interstitial syndrome, resulting in moderate loss of aeration with more than three spaced B-lines, 7mm apart, scores one point.
- 2: Alveolar-interstitial syndrome meaning a severe loss of aeration with coalescent B-lines, less then 3mm apart, scores two.
- 3: An alveolar consolidation leading to a complete loss of aeration with an ultrasonographic tissue like pattern.
LUSS will be calculated by adding the score given to each 12 zones, with a maximum of thirty-six. Patients scoring less than two, will be considered empirically with no interstitial syndrome and will be excluded of the study.
Investigators will also report the presence of pleural effusions and if present estimate their amount. If present, pleural effusions quantification will be realized at lung base. The maximal distance between parietal and visceral pleura (Dmax) in millimeter will be measured after freezing the image in end-expiration.
If the ABG indication according to treating ICU physician persist, the complete intervention including calculation of LUSS, research and quantification of pleural effusions will be repeated at twenty-four and forty-eight hours.
Result of LUSS, pleural effusions' presence and Dmax won't be communicated to the treating physician expect if the LUS results could influence patient prognosis.
STUDY CONDUCTION
Study Settings:
Before the study launching, the investigator will be evaluated using a five-point Likert scale as previously described. A presentation of the study and the procedure will be organized by the coordinating investigators in each center.
Patients' recruitment:
The eligible patients will be identified by the treating ICU physician. Adult patients admitted to ICU with signs and symptoms of ARF and an indication of realization of ABG to evaluate PaO2 according to treating ICU physician will be considered for inclusion. ABG won't be considered as an intervention as the decision of the realization of an ABG is being left to the treating ICU physician. If those criteria are met, treating physician will contact an investigator.
Inclusion:
Investigator will be responsible to verify if patient meet all inclusion criteria. Consent will correspond to the signature of a paper consent form in duplicate after being informed over research modalities by the investigator. If the patient is unable to give his consent because of an acute condition and have no legal representative, a delayed consent will be authorized. One signed copy of the consent form will be returned to the patient or the legal representative.
Intervention:
All included patients will undergo a LUS, the calculation of a LUSS and search of pleural effusions and pleural effusions' quantification by Dmax measurement when pleural effusions are present. In Belgium, LUS isn't recognized as standard of care giving to this study an interventional character. Intervention will take place in a range of time of maximum then minutes before or after ABG realization. The result of the intervention will not be communicated to the treating physician except when LUS could influence patient's prognosis.
Follow up:
If ABG indication persists following treating ICU physician and if the patient is still present in the ICU, the intervention as described previously will be repeated at twenty-four and forty-eight hours.
Data collection and Data treatment:
After inclusion data will be reported in an informatized CRF using REDCap software by investigator and Pleural Effusion Volume (Vpe) in milliliter will be automatically calculated by multiplying Dmax per twenty according to Balik and all's formula. The SOFA score at inclusion, twenty-four and forty-eight hours will also be calculated and recorded. Name, first name, date of birth and hospital administrative number of the included patients will be recorded. Investigators will only access personal data of the patient they have personally included. Principal investigators will have access to all personal data to be able to collect missing data. After data completion, a neutral identifier composed by inclusion centre's number, number of inclusion and year of birth will be used. A correspondence list will be kept under the principal investigator responsibility.
STATISTICS
Data analysis was performed using JMP Pro 16.0.0 Software (SAS Institute). Continuous variables are expressed as mean values and standard deviations. Discrete variables are reported as categories and expressed as numbers and percentages. The Pearson correlation was used to measure the linear correlation between continuous variables, and correlations are expressed as correlation coefficient and 95% confidence interval. Comparisons between quantitative data were performed with a χ2 test, and between-group comparisons between continuous data with a Wilcoxon-Mann-Whitney test. The significance threshold was set with a P value of < 0.05. A one-sided hypothesis test will be use to show the improvement of the correlation between PaO2/FiO2 and LUSS. Pearson formula will be used to show correlation between PaO2/FiO2 and LUSS. Multiple linear regression will be used to test the effects of continuous variables such as presence of pleural effusions on the correlation between PaO2/FIO2 and LUSS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Population | Experimental | Other: Lung UltrasoundAll patients included in the study, meaning patients in the ICU presenting an interstitial syndrom no matter the aetiology |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- consent
- ->17 years old
Key exclusion criteria (8 listed)
- LUSS < 2
- Patient with pathologies leading to chronic IS
- Chronic Obstructive Pulmonary Disease (COPD) or active asthma
- Patients under veino-veinous or veino-arterial " Extracorporeal Membrane Oxygenation " (ECMO)
- Severe trauma patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung UltrasoundEvaluation of the Lung Ultrasound Score in patients presenting an interstitial syndrom on the lung ultrasound and to compare it with PaO2/FiO2 | Other | Patient Population |
Primary outcome
Correlation PaO2/FiO2 and LUSS
Time frame: At inclusion
To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS.
29 secondary outcomes
Evolution
Time frame: Twenty four and forty eight hours
Lung Ultrasound Score and SOFA score
Time frame: Inclusion,twenty four and forty eight hours
Influence SOFA on the correlation between PaO2/FiO2 and LUSS
Time frame: Inclusion,twenty four and forty eight hours
Pleural Effusions
Time frame: Inclusion, twenty four and forty eight hours
Correlation PaO2/FiO2 and the LUSS according to IS diagnosis
Time frame: Inclusion
Correlation between the PaO2/FiO2 and the LUSS admission diagnosis
Time frame: Inclusion
Correlation between the PaO2/FiO2 and the LUSS according to the LUSS value
Time frame: Inclusion
Correlation between the PaO2/FiO2 and LUSS according to hypoxemia
Time frame: Inclusion
Correlation between the PaO2/FiO2 and LUSS according to the RR at admission
Time frame: Inclusion
Evolution of the correlation between the PaO2/FiO2 and the LUSS according to IS diagnosis
Time frame: Twenty four and forty eight hours
Evolution of the correlation between the PaO2/FiO2 and the LUSS according to admission diagnosis
Time frame: Twenty four and forty eight hours
Evolution of the correlation between the PaO2/FiO2 and the LUSS according to LUSS value
Time frame: Twenty four and forty eight hours
Evolution of the correlation between the PaO2/FiO2 and the LUSS according to hypoxemia severity
Time frame: Twenty four and forty eight hours
Evolution of the correlation between the PaO2/FiO2 and the LUSS according RR
Time frame: Twenty four and forty eight hours
Correlation between LUSS and the SOFA score at inclusion according to the diagnosis of the IS
Time frame: Inclusion,twenty four and forty eight hours
Correlation between LUSS and the SOFA score at inclusion according to admission diagnosis
Time frame: Inclusion,twenty four and forty eight hours
Correlation between LUSS and the SOFA score according to the LUSS value
Time frame: Inclusion,twenty four and forty eight hours
Correlation between LUSS and the SOFA score according to hypoxemia severity
Time frame: Inclusion,twenty four and forty eight hours
Correlation between LUSS and the SOFA score according to the RR
Time frame: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to IS diagnosis
Time frame: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to admission diagnosis
Time frame: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to LUSS value
Time frame: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to hypoxemia severity
Time frame: Inclusion,twenty four and forty eight hours
Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to RR
Time frame: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to IS diagnosis
Time frame: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to admission diagnosis
Time frame: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to LUSS value
Time frame: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to hypoxemia severity
Time frame: Inclusion,twenty four and forty eight hours
Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to RR
Time frame: Inclusion,twenty four and forty eight hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 16984837Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
- Background: PubMed 22392031Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 9372688Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.
- Background: PubMed 30372119Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.
- Background: PubMed 25829314Zieleskiewicz L, Cornesse A, Hammad E, Haddam M, Brun C, Vigne C, Meyssignac B, Remacle A, Chaumoitre K, Antonini F, Martin C, Leone M. Implementation of lung ultrasound in polyvalent intensive care unit: Impact on irradiation and medical cost. Anaesth Crit Care Pain Med. 2015 Feb;34(1):41-4. doi: 10.1016/j.accpm.2015.01.002. Epub 2015 Mar 5.
- Background: PubMed 28903756Brogi E, Bignami E, Sidoti A, Shawar M, Gargani L, Vetrugno L, Volpicelli G, Forfori F. Could the use of bedside lung ultrasound reduce the number of chest x-rays in the intensive care unit? Cardiovasc Ultrasound. 2017 Sep 13;15(1):23. doi: 10.1186/s12947-017-0113-8.
- Background: PubMed 14695718Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006.
- Background: PubMed 15888847Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. doi: 10.1378/chest.127.5.1690.
- Background: PubMed 19168766Soldati G, Copetti R, Sher S. Sonographic interstitial syndrome: the sound of lung water. J Ultrasound Med. 2009 Feb;28(2):163-74. doi: 10.7863/jum.2009.28.2.163.
- Background: PubMed 15135701Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70. doi: 10.1016/j.amjcard.2004.02.012.
- Background: PubMed 6152918Ziskin MC, Thickman DI, Goldenberg NJ, Lapayowker MS, Becker JM. The comet tail artifact. J Ultrasound Med. 1982 Jan-Feb;1(1):1-7. doi: 10.7863/jum.1982.1.1.1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleonore Vasseur, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Ultrasound in people with Interstitial Lung Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation PaO2/FiO2 and LUSS (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631756, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.