Effect of PEEP on Lung Recruitment and Homogeneity Over Time in Moderate to Severe ARDS (NCT03140579) | Clinical Trial Compass
WithdrawnNot Applicable
Effect of PEEP on Lung Recruitment and Homogeneity Over Time in Moderate to Severe ARDS
Stopped: Study not undertaken due to COVID and capacity
United Kingdom0Started 2018-06-01
Plain-language summary
This study evaluates the effect of airway pressure release ventilation (APRV) on lung homogeneity and recruitment in patients with moderate to severe acute respiratory distress syndrome (ARDS).
It will do this by comparing the homogeneity of ventilation and recruitment prior to a patient being ventilated on APRV, and at 30, 60 and 120 minutes after starting APRV.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years and \< 80 years
* Weight \> 35 Kg and BMI \< 40
* Informed consent according to local regulations
* Hemoglobin ≥ 70 g/dl
* Haemodynamically stable \> 4 hours
* Moderate to severe ARDS (PaO2/FIO2 \< 26.6 kPa with positive end-expiratory pressure (PEEP) \> 5 cmH2O) as per Berlin definition of ARDS
Exclusion Criteria:
* Expected survival \< 72 hours
* Suspected pregnancy (negative pregnancy test required for women of child-bearing potential)
* Open abdomen
* Documented or suspected raised intracranial pressure
* Active air leak (pneumothorax, pneumomediastinum, subcutaneous emphysema)
* Morbid obesity BMI \> 40
* Recent \< 1 week cardiac or thoracic surgery
* Unstable thorax and sternum with paradoxical chest wall movement
* Severe Chronic Respiratory Disease (COPD) - GOLD 3 or 4 emphysema with bullae
* Severe smoking (\> 40 pack-year history)
* Liver Failure: Child-Pugh Class C
* Massive ascites
* Lung fibrosis
* Severe cardiac disease (one of the following): New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias
* Sickle cell disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare lung homogeneity estimated with EIT upon commencing APRV (APRVpre) and after 30 - 60 - 120 min of APRV ventilation (APRV30, APRV60, APRV120) in patients with moderate to severe ARDS