PneumniaNCT06678035
Use of Simplified Lung Ultrasound Score for Predicting ICU Outcomes in Patients With Acute Respiratory Failure
An observational study of Pneumnia and Chest Infection, run by Assiut University.
Trial summary
This study aims to Primary Aims: Verify the predictability of the PLIS at admission in predicting major clinical outcomes including: ICU mortality (or discharge) and time to death (or discharge) Escalation of ventilatory support antibiotic therapy or supportive medications (inotropes, steroids, sedation, neuromuscular… Read more about this study
- Who is it for?
- Ages 18 days and older
- Conditions the study is for
- Pneumnia, Chest Infection, Critically-ill Patients Admitted to the ICU for Acute Respitatory Failure, Regardless the Aetilogy
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 1 Oct 2025
- Phase
- Observational
- 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 18 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are more than 18 years in repiratory failure in ICU and use of chest us in supine or semisupine position
Who may be able to join
- Age is or more than 18 years old.
- Admission to ICU in the first24 hours at time of recruitment to the study.
- Patients in respiratory failure [PaO2 is less then 60 % mmHg]
Who cannot join
- Co- existing chronic lung disease, pathology of which is known display abnormalities on US examination (interstitial lung diseases, bronchiectasis).
- Large pneumothorax or massive pleural effusion causing significant collapse and precluding proper visualization of underlying lung.
- Conditions that may interfere with lung ultrasound quality or probe contact such as marked obesity, severe chest wall deformities, burns or wounds.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to
Primary Aims:
Read more
Verify the predictability of the PLIS at admission in predicting major clinical outcomes including:
- ICU mortality (or discharge) and time to death (or discharge)
- Escalation of ventilatory support antibiotic therapy or supportive medications (inotropes, steroids, sedation, neuromuscular blockers).
Secondary Aims:
- Determine the correlation between initial PLIS and the degree of disease severity (as evaluated per SOFA and APACHE II scores)
- Determine the correlation between initial PLIS and partial pressure of oxygen in arterial blood (PaO2) to Fraction of inspired oxygen (FiO2): PaO2/FiO2
- Explore the potential association between the type of ventilatory support, ventilatory settings and PLIS at different time points.
- Verify whether the site of consolidation (anterior vs. posterior lung zones) can reliably predict mortality in in ALI patients.
- Determine the correlation between the PLIS score and the degree of ALI as quantified by CT of the chest (whenever a CT study is available) at the time of admission.
Read the detailed description
Respiratory failure and acute lung injury (ALI) in patients admitted to ICU are major causes of morbidity And mortality As high as 60 % of ICU population dii during their ICU admission due to ALI Accurate assessment of the severity of ALI is Crucial for guiding treatment decisions and predicting patient outcome Reliance on chest X-ray and Computed tomography has its limitations including subjectivity and potential delays in obtaining and interpreting results high cost radiation exposure and lack of continuous monitoring particularly for critically ill patients Ultrasound -being non-invasive low cost radiation free- has been increasingly used as a bedside tool for evaluation and monitoring of ALI However most lung ultrasound protocols published to date are cumbersome and time consuming They typically involve screening at least 12 different lung areas each graded from 0 to 3 point thus generating scores ranging from 0 to 36 .While these scores are informative for research purposes they are less practical in a busy or ICU environment Also disregarding the site of B-lines or consolidation and the size of consolidation potentially under-estimates the severity of ALI Recently a novel -yet comprehensive- point of care ultrasound lung injury score has been developed to aid informative and quick assessment of ALI in ICU PLIS involves screening of only 3 areas but it uniquely considers the level of ventilatory support and gives credit to the number of B lines size of consolidation location of consultation The score reliably predicted to the need of ICU admission in a group off of COVID 19 patients directly correlation with their SOFA scores also predicted ICU mortality in this patient However Wider adoption of PLIS by intensivists dictates evaluation of its performance in a wider ICU population with a variety of underlying diagnoses This study is to verify whether PLIS remains valid for predicting ICU outcomes in patients with acute respiratory failure regardless the etiology type of respiratory failure oxygen requirement level of ventilatory support
- Conditions
- Pneumnia, Chest Infection, Critically-ill Patients Admitted to the ICU for Acute Respitatory Failure, Regardless the Aetilogy
- Keywords
- LUS, Acute respiratory failure, Critically-ill patients
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Percentage of patients who will die during their ICU admission
Measured: 60 days
Time to death/discharge
Number of days until the patient dies inside the ICU or becomes discharged from ICU
Measured: 60 days
Secondary outcomes (3)
Need for Therapy escalation: Ventilatory Support
Binary response (yes or no), to whether the type of ventilatory support (COT-HVNI-NIV-IMV) was escalated or not
Measured: 60 days
Need for Therapy Escalation: Ventilatory seetings
Binary response (yes or no) to whether change in ventilatory settings (FiO2, IPAP, EPAP, Ti,TVe) was needed
Measured: 60 days
Need for Therapy Escalation: Medications
Binary response (yes/no) to whether medications like antibiotics, inotropes, sedation, or NMBs, which were not initiated needed to be added or not
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumniaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Zakaria Hassab Elnabi Shahin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678035
- Sponsor's protocol ID
- Chest US in ICU
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbi L, Viani A, Giaroni F, Ruggieri V, Cerri S, Clini E. Ultrasound-assessed diaphragmatic impairment is a predictor of outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease undergoing noninvasive ventilation. Crit Care. 2018 Apr 27;22(1):109. doi: 10.1186/s13054-018-2033-x.
PubMed 29703214Biasucci DG, Buonsenso D, Piano A, Bonadia N, Vargas J, Settanni D, Bocci MG, Grieco DL, Carnicelli A, Scoppettuolo G, Eleuteri D, DE Pascale G, Pennisi MA, Franceschi F, Antonelli M; Gemelli Against COVID-19 Group. Lung ultrasound predicts non-invasive ventilation outcome in COVID-19 acute respiratory failure: a pilot study. Minerva Anestesiol. 2021 Sep;87(9):1006-1016. doi: 10.23736/S0375-9393.21.15188-0. Epub 2021 Jul 14.
PubMed 34263580
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Simplified Lung Ultrasound Score for Predicting ICU Outcomes in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT06678035
- Acronym / sponsor ID
- Chest US in ICU
- Conditions
- Pneumnia, Chest Infection, Critically-ill Patients Admitted to the ICU for Acute Respitatory Failure, Regardless the Aetilogy
- Keywords
- LUS, Acute respiratory failure, Critically-ill patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 7 Nov 2024 (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.
This study aims to
Primary Aims:
Verify the predictability of the PLIS at admission in predicting major clinical outcomes including:
- ICU mortality (or discharge) and time to death (or discharge)
- Escalation of ventilatory support antibiotic therapy or supportive medications (inotropes, steroids, sedation, neuromuscular blockers).
Secondary Aims:
- Determine the correlation between initial PLIS and the degree of disease severity (as evaluated per SOFA and APACHE II scores)
- Determine the correlation between initial PLIS and partial pressure of oxygen in arterial blood (PaO2) to Fraction of inspired oxygen (FiO2): PaO2/FiO2
- Explore the potential association between the type of ventilatory support, ventilatory settings and PLIS at different time points.
- Verify whether the site of consolidation (anterior vs. posterior lung zones) can reliably predict mortality in in ALI patients.
- Determine the correlation between the PLIS score and the degree of ALI as quantified by CT of the chest (whenever a CT study is available) at the time of admission.
Detailed description
Respiratory failure and acute lung injury (ALI) in patients admitted to ICU are major causes of morbidity And mortality As high as 60 % of ICU population dii during their ICU admission due to ALI Accurate assessment of the severity of ALI is Crucial for guiding treatment decisions and predicting patient outcome Reliance on chest X-ray and Computed tomography has its limitations including subjectivity and potential delays in obtaining and interpreting results high cost radiation exposure and lack of continuous monitoring particularly for critically ill patients Ultrasound -being non-invasive low cost radiation free- has been increasingly used as a bedside tool for evaluation and monitoring of ALI However most lung ultrasound protocols published to date are cumbersome and time consuming They typically involve screening at least 12 different lung areas each graded from 0 to 3 point thus generating scores ranging from 0 to 36 .While these scores are informative for research purposes they are less practical in a busy or ICU environment Also disregarding the site of B-lines or consolidation and the size of consolidation potentially under-estimates the severity of ALI Recently a novel -yet comprehensive- point of care ultrasound lung injury score has been developed to aid informative and quick assessment of ALI in ICU PLIS involves screening of only 3 areas but it uniquely considers the level of ventilatory support and gives credit to the number of B lines size of consolidation location of consultation The score reliably predicted to the need of ICU admission in a group off of COVID 19 patients directly correlation with their SOFA scores also predicted ICU mortality in this patient However Wider adoption of PLIS by intensivists dictates evaluation of its performance in a wider ICU population with a variety of underlying diagnoses This study is to verify whether PLIS remains valid for predicting ICU outcomes in patients with acute respiratory failure regardless the etiology type of respiratory failure oxygen requirement level of ventilatory support
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are more than 18 years in repiratory failure in ICU and use of chest us in supine or semisupine position
Key inclusion criteria (3 listed)
- Age is or more than 18 years old.
- Admission to ICU in the first24 hours at time of recruitment to the study.
- Patients in respiratory failure [PaO2 is less then 60 % mmHg]
Key exclusion criteria (3 listed)
- Co- existing chronic lung disease, pathology of which is known display abnormalities on US examination (interstitial lung diseases, bronchiectasis).
- Large pneumothorax or massive pleural effusion causing significant collapse and precluding proper visualization of underlying lung.
- Conditions that may interfere with lung ultrasound quality or probe contact such as marked obesity, severe chest wall deformities, burns or wounds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU Mortality
Time frame: 60 days
Percentage of patients who will die during their ICU admission
Time to death/discharge
Time frame: 60 days
Number of days until the patient dies inside the ICU or becomes discharged from ICU
3 secondary outcomes
Need for Therapy escalation: Ventilatory Support
Time frame: 60 days
Need for Therapy Escalation: Ventilatory seetings
Time frame: 60 days
Need for Therapy Escalation: Medications
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Results publication: PubMed 29703214Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbi L, Viani A, Giaroni F, Ruggieri V, Cerri S, Clini E. Ultrasound-assessed diaphragmatic impairment is a predictor of outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease undergoing noninvasive ventilation. Crit Care. 2018 Apr 27;22(1):109. doi: 10.1186/s13054-018-2033-x.
- Results publication: PubMed 34263580Biasucci DG, Buonsenso D, Piano A, Bonadia N, Vargas J, Settanni D, Bocci MG, Grieco DL, Carnicelli A, Scoppettuolo G, Eleuteri D, DE Pascale G, Pennisi MA, Franceschi F, Antonelli M; Gemelli Against COVID-19 Group. Lung ultrasound predicts non-invasive ventilation outcome in COVID-19 acute respiratory failure: a pilot study. Minerva Anestesiol. 2021 Sep;87(9):1006-1016. doi: 10.23736/S0375-9393.21.15188-0. Epub 2021 Jul 14.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumnia and Chest Infection, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Zakria Hassab Elnabi, resident doctor (+201145682833, mony.zak05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: 60 days). The study lists 2 primary outcomes in all. 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 NCT06678035, which also lists 2 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 7 Nov 2024.