Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia (NCT04349618) | Clinical Trial Compass
CompletedNot Applicable
Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia
France220 participantsStarted 2020-04-15
Plain-language summary
Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19 patients may be particularly at risk for ventilator-induced lung injury. Treatment of COVID-19 ARDS patients is to date mainly supportive with protective mechanical ventilation (ventilation with low tidal volume (VT) i.e. 6 ml/kg of predicted body weight (PBW) and plateau pressure control below 30 cm H2O).
Mechanical ventilation with VT reduction below 6 ml/kg PBW in ARDS may reduce alveolar strain, driving pressure and hence ventilator-induced lung injury. Investigators recently performed a multicenter pilot study on 34 moderately severe to severe ARDS patients. This study demonstrated that ultraprotective ventilation with ultra-low VT (≤4.2 ml/kg PBW) without extracorporeal circulation may be applied in approximately 2/3 of the patients, with a 4 cmH2O median reduction in driving pressure, at the price of transient episodes of severe acidosis in approximately 1/3 of the patients. Investigators hypothesized that ultraprotective ventilation without extracorporeal circulation may reduce the mortality at day-90 and increase the number of days free from mechanical ventilation (VFD) at day-60, as compared to protective ventilation.
Who can participate
Age range
18 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:
* Adults aged 18 years or older
* ARDS according to the Berlin definition
* COVID-19 pneumonia confirmed by RT-PCR
* Acute respiratory failure not fully explained by left ventricular failure or sodium overload
* Bilateral pulmonary radiological opacities not fully explained by pleural effusions or atelectasis or nodules
* Invasive mechanical ventilation with PaO2/FiO2 ≤ 150 mm Hg and PEEP ≥ 5 cm H2O with a tidal volume below or equal to 6 ml per kilogram of predicted body weight
* Continuous intravenous sedation as part of ARDS treatment
Exclusion Criteria:
* Exclusion criteria related to ARDS history
* ARDS onset more than 48 hours before inclusion
* previous inclusion in present study
* Exclusion criteria related to ARDS severity or complications
* arterial pH \< 7.21 despite respiratory rate set to 35/min at the time of inclusion
* patient under any extracorporeal CO2 removal technique or ECMO
* pneumothorax or bronchopleural fistula
* Exclusion criteria related to comorbidities
* suspected intracranial hypertension
* severe chronic obstructive pulmonary disease defined by a GOLD score ≥ 3
* chronic respiratory failure under home oxygen or non-invasive ventilation
* chronic respiratory failure requiring long term oxygen or non-invasive ventilation
* obesity with body weight over height ratio greater than 1 kg/cm
* sickle cell disease
* bone marrow transplant \< 6 months
* burn injury with extension greater than 30% of bod…
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
A composite score based on all-cause mortality and the number of ventilator free-days (VFD)