"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme" (CALMDOWN)

Assistance Publique - Hôpitaux de Paris

Status and phase: Enrolling; Phase 3

Conditions: Extracorporeal Membrane Oxygenation Complication; Acute Respiratory Distress Syndrome

Treatments: Device: ECMO + near apneic ventilation; Device: ECMO + ultra-protective lung ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT06814340

APHP230850

Details and patient eligibility

About

The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation).

The study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ARDS) rescued by ECMO.

Indeed, our hypothesis is that that early (near) apneic ventilation on venovenous ECMO for severe ARDS can enhance ventilator injury prevention and therefore reduce ECMO duration and mortality at Day 60.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.
2. Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patient is unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow.
3. Social security registration (except AME)

Exclusion criteria

1. Age < 18
2. Pregnancy or breastfeeding
3. Initiation of VV-ECMO > 48 h (maximum tolerance : +2h)
4. Cardiac arrest with cumulated no flow time &amp;gt;10 minutes before ECMO (within 48 hours prior to inclusion)
5. Irreversible neurological pathology
6. End-stage chronic lung disease
7. Contraindications for high PEEP level: untreated pneumothorax, barotrauma
8. Irreversible ARDS with no hope for lung function recovery
9. Patient moribund on the day of randomization, SAPS II &amp;gt;90
10. Liver cirrhosis (Child B or C)
11. Lung transplantation
12. Burns on more than 20 % of the body surface
13. Participation in another interventional study or being in the exclusion period at the end of a previous study, expect DRESSING-ECMO trial, which evaluates the use of sterile adhesive transparent dressings impregnated with Chlorhexidine gluconate on the cumulative incidence of ECMO cannula-related infection episodes.
14. Individuals under guardianship, or permanently legally incompetent adults

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Intervention group : near apneic ventilation

Experimental group

Description:

Patients will received near apneic ventilation during the first 3 days of ECMO.

Treatment:

Device: ECMO + near apneic ventilation

Standard of care : ultra-protective lung ventilation

Active Comparator group

Description:

Patients will receive ultra-protective lung ventilation as it uses on usual care on ECMO.

Treatment:

Device: ECMO + ultra-protective lung ventilation