Status:
COMPLETED
Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Acute Respiratory Distress Syndrome
COVID19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 appea...
Eligibility Criteria
Inclusion
- 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
- 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 body surface area
- cirrhosis with Child-Pugh score C
- advance directives to withhold or withdraw life sustaining treatment
- Exclusion criteria related to legislation
- Patient under an exclusion period relative to participation to another clinical trial, or inclusion into a clinical trial interfering with the ventilatory strategies
- pregnancy, lactating women
- patient under a legal protective measure.
- lack of affiliation to social security as required by French regulation
- lack of written informed consent by patient or next of kin (unless if recourse to the emergency procedure in the absence of a loved one)
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04349618
Start Date
April 15 2020
End Date
June 16 2022
Last Update
December 10 2025
Active Locations (11)
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1
Service de Médecine Intensive Réanimation CHU Gabriel Montpied
Clermont-Ferrand, France, 63003
2
Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes
La Tronche, France, 38700
3
Service de Médecine Intensive Réanimation Hôpital Edouard Herriot Hospices Civils de Lyon
Lyon, France, 69003
4
Service de Réanimation Chirurgicale Hôpital Edouard Herriot Hospices Civils de Lyon
Lyon, France, 69003