Acute Respiratory Distress SyndromeNCT06971042
Early Diagnosis of ARDS in Mechanically Ventilated Patient Using LUS Score in Comparison With CT
An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation Complication, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to assess accuracy of Lung ultrasound score for early diagnosis of acute respiratory distress syndrome in patients who expected to be mechanically ventilated more than 24 hour in comparison with computed tomography chest . Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Mechanical Ventilation Complication, Computed Tomography
- What is being tested?
- Lung Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to 20 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted in surgical Intensive care unit that mechanically ventilated more than 24 hours who fulfill criteria of Acute Respiratory Distress Syndrome according to Berlin definition.
Who may be able to join
- Patients aged more than 21 years old of both sexes .
- Patients who are expected to be mechanically ventilated more than 24 h .
- Patients who are suspected to be Acute Respiratory Distress Syndrome according to Berlin definition which consists of clinical criteria and with precipitating factors which starts within 1 week of known insult as in trauma patients with lung contusions.
Who cannot join
- Patient's first guardian who refuse the inclusion in the study .
- History of pre-existing lung disease ( tumors, interstitial lung diseases)
- In cases of volume overload.
- Patients with acute kidney injuiry or renal failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university
Tanta, 31527
Roaa Elshamy, MSc, 01275530586 ext. +2, r1shamy@yahoo.com
About this study
Official title: Early Diagnosis of Acute Respiratory Distress Syndrome (ARDS) in Mechanically Ventilated Patient Using Lung Ultrasound Score in Comparison With CT Chest
The aim of this study is to assess accuracy of Lung ultrasound score for early diagnosis of acute respiratory distress syndrome in patients who expected to be mechanically ventilated more than 24 hour in comparison with computed tomography chest .
Read the detailed description
Acute respiratory distress syndrome is an acute, diffuse, inflammatory form of lung injury and life-threatening condition in seriously ill patients, characterized by poor oxygenation, pulmonary infiltrates, and acute onset. on a microscopic level, the disorder is associated with capillary endothelial injury and diffuse alveolar damage Acute respiratory distress syndrome is an acute disorder that starts within seven days of the inciting event and is characterized by bilateral lung infiltrates and severe progressive hypoxemia in the absence of any evidence of cardiogenic pulmonary edema. According to the Berlin definition, Acute respiratory distress syndrome is defined by acute onset, bilateral lung infiltrates on chest radiography or computed tomography scan of a non-cardiac origin, and a PaO2/FiO2 ratio of less than 300 mm Hg. The Berlin definition differs from the previous American-European Consensus definition by excluding the term acute lung injury; it also removed the requirement for wedge pressure < 18 mm Hg and included the requirement of positive end-expiratory pressure or continuous positive airway pressure of greater than or equal to 5 cm H20.
Once Acute respiratory distress syndrome develops, patients usually have varying degrees of pulmonary artery vasoconstriction and may subsequently develop pulmonary hypertension. Acute respiratory distress syndrome carries a high mortality, and few effective therapeutic modalities exist to combat this condition Although the Berlin definition of Acute respiratory distress syndrome was a major step forward, some of its limitations were recognized soon after publication. Specifically, it was recognized that its requirement for noninvasive ventilation or invasive ventilation could not be met in settings in which these modalities are not available So consensus conference of 32 critical care develop new global Acute respiratory distress syndrome definition that use high flow nasal oxygen , pulse oximetry in place of arterial blood gas and use of Lung ultrasound to suit limited resource setting .
Lung computed tomography scan is the gold standard in diagnosis of Acute respiratory distress syndrome can provide useful diagnostic information and assess the benefit of treatment. However, this procedure is done in a computed tomography unit under cardiorespiratory monitoring with an increased risk to the patient.
Diagnostic and lung exploratory ultrasound is a rapidly evolving technique used in the Intensive care unit environment, being considered noninvasive, radiation-free, cheap, and easy to perform .
Lung ultrasound has been validated for hemodynamic management, pleural effusions, pulmonary edema, pneumothorax detection, parenchymal consolidation, and central vein catheter placement .
simple and short Lung ultrasound examination could predict prone position oxygenation response in Acute respiratory distress syndrome patients .
Scores based on detection of B-lines (the sonographic sign of increased lung density associated with interstitial syndrome) and on consolidation have been correlated with global and regional lung aeration as assessed by computed tomography chest.
Lung ultrasound has been proposed as an accurate bedside and radiation free technique for evaluation of lung consolidations and for follow-up of aeration changes in response to interventions.
However lung us scoring system hasn't been included in Acute respiratory distress syndrome definition and didn't prefer image modality in diagnosis of Acute respiratory distress syndrome , therefore our study will explore the feasibility and accuracy of lung us score performed bedside to differentiate between Acute respiratory distress syndrome and non Acute respiratory distress syndrome patient compared to lung computed tomography .
- Conditions
- Acute Respiratory Distress Syndrome, Mechanical Ventilation Complication, Computed Tomography
- Being tested
- Lung Ultrasound
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundRadiation
Also called Lung computed tomography
Patients were examined in supine position, using a portable ultrasound machine equipped with a curvilinear transducer (5-3 MHz)
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Acute respiratory distress syndrome
Accuracy of lung ultrasound score in diagnosis of Acute respiratory distress syndrome in comparison with Lung computed tomography .
Measured: Within 48 hours
Secondary outcomes (1)
Severity of Acute respiratory distress syndrome .
Accuracy of lung ultrasound score in assessment severity of Acute respiratory distress syndrome .
Measured: Within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start10 Aug 2024
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roaa Mohamed Ibrahim Elshamy, Tanta University
- Investigators
- Roaa Elshamy, MSc, Principal investigator, Tanta UniversityRoaa Elshamy, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971042
- Sponsor's protocol ID
- 36264MS675/8/24
- Status last verified
- Jun 2025
- First submitted
- 6 May 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be available upon the reasonable request from the principle
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Acute Respiratory Distress Syndrome (ARDS) in Mechanically Ventilated Patient Using Lung Ultrasound Score in Comparison With CT Chest
- ClinicalTrials.gov ID
- NCT06971042
- Acronym / sponsor ID
- 36264MS675/8/24
- Conditions
- Acute Respiratory Distress Syndrome, Mechanical Ventilation Complication, Computed Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 14 May 2025 (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 aim of this study is to assess accuracy of Lung ultrasound score for early diagnosis of acute respiratory distress syndrome in patients who expected to be mechanically ventilated more than 24 hour in comparison with computed tomography chest .
Detailed description
Acute respiratory distress syndrome is an acute, diffuse, inflammatory form of lung injury and life-threatening condition in seriously ill patients, characterized by poor oxygenation, pulmonary infiltrates, and acute onset. on a microscopic level, the disorder is associated with capillary endothelial injury and diffuse alveolar damage Acute respiratory distress syndrome is an acute disorder that starts within seven days of the inciting event and is characterized by bilateral lung infiltrates and severe progressive hypoxemia in the absence of any evidence of cardiogenic pulmonary edema. According to the Berlin definition, Acute respiratory distress syndrome is defined by acute onset, bilateral lung infiltrates on chest radiography or computed tomography scan of a non-cardiac origin, and a PaO2/FiO2 ratio of less than 300 mm Hg. The Berlin definition differs from the previous American-European Consensus definition by excluding the term acute lung injury; it also removed the requirement for wedge pressure < 18 mm Hg and included the requirement of positive end-expiratory pressure or continuous positive airway pressure of greater than or equal to 5 cm H20.
Once Acute respiratory distress syndrome develops, patients usually have varying degrees of pulmonary artery vasoconstriction and may subsequently develop pulmonary hypertension. Acute respiratory distress syndrome carries a high mortality, and few effective therapeutic modalities exist to combat this condition Although the Berlin definition of Acute respiratory distress syndrome was a major step forward, some of its limitations were recognized soon after publication. Specifically, it was recognized that its requirement for noninvasive ventilation or invasive ventilation could not be met in settings in which these modalities are not available So consensus conference of 32 critical care develop new global Acute respiratory distress syndrome definition that use high flow nasal oxygen , pulse oximetry in place of arterial blood gas and use of Lung ultrasound to suit limited resource setting .
Lung computed tomography scan is the gold standard in diagnosis of Acute respiratory distress syndrome can provide useful diagnostic information and assess the benefit of treatment. However, this procedure is done in a computed tomography unit under cardiorespiratory monitoring with an increased risk to the patient.
Diagnostic and lung exploratory ultrasound is a rapidly evolving technique used in the Intensive care unit environment, being considered noninvasive, radiation-free, cheap, and easy to perform .
Lung ultrasound has been validated for hemodynamic management, pleural effusions, pulmonary edema, pneumothorax detection, parenchymal consolidation, and central vein catheter placement .
simple and short Lung ultrasound examination could predict prone position oxygenation response in Acute respiratory distress syndrome patients .
Scores based on detection of B-lines (the sonographic sign of increased lung density associated with interstitial syndrome) and on consolidation have been correlated with global and regional lung aeration as assessed by computed tomography chest.
Lung ultrasound has been proposed as an accurate bedside and radiation free technique for evaluation of lung consolidations and for follow-up of aeration changes in response to interventions.
However lung us scoring system hasn't been included in Acute respiratory distress syndrome definition and didn't prefer image modality in diagnosis of Acute respiratory distress syndrome , therefore our study will explore the feasibility and accuracy of lung us score performed bedside to differentiate between Acute respiratory distress syndrome and non Acute respiratory distress syndrome patient compared to lung computed tomography .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted in surgical Intensive care unit that mechanically ventilated more than 24 hours who fulfill criteria of Acute Respiratory Distress Syndrome according to Berlin definition.
Key inclusion criteria (3 listed)
- Patients aged more than 21 years old of both sexes .
- Patients who are expected to be mechanically ventilated more than 24 h .
- Patients who are suspected to be Acute Respiratory Distress Syndrome according to Berlin definition which consists of clinical criteria and with precipitating factors which starts within 1 week of known insult as in trauma patients with lung contusions.
Key exclusion criteria (4 listed)
- Patient's first guardian who refuse the inclusion in the study .
- History of pre-existing lung disease ( tumors, interstitial lung diseases)
- In cases of volume overload.
- Patients with acute kidney injuiry or renal failure
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 UltrasoundAlso: Lung computed tomographyPatients were examined in supine position, using a portable ultrasound machine equipped with a curvilinear transducer (5-3 MHz) | Radiation | – |
Primary outcome
Diagnosis of Acute respiratory distress syndrome
Time frame: Within 48 hours
Accuracy of lung ultrasound score in diagnosis of Acute respiratory distress syndrome in comparison with Lung computed tomography .
1 secondary outcome
Severity of Acute respiratory distress syndrome .
Time frame: Within 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Undecided. The data will be available upon the reasonable request from the principle
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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.
Roaa Elshamy, MSc principal investigator
Tanta University
Roaa Elshamy principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation Complication, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roaa Elshamy, MSc (01275530586 ext. +2, r1shamy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Acute respiratory distress syndrome (time frame: Within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.