Domain Lead Investigators
Resources
- Download IMV-ECLS Domain Protocol v1.0 (pdf:1.7MB)
- Download IMV-ECLS_PEEP-10 Intervention Appendix_v.1.0 (pdf:1.2MB)
- Download IMV-ECLS_PEEP-20 Intervention Appendix_v.1.0 (pdf:1.0MB)
- Download IMV-ECLS_PEEP-AOP Intervention Appendix_v.1.0 (pdf:1.0MB)
Domain Description
Objective | To identify the mechanical ventilation strategies that most effectively improve outcomes in patients receiving venovenous extracorporeal life support. |
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Population | Patients with severe acute hypoxemic respiratory failure who have been consented to extracorporeal life support, or who have been cannulated to extracorporeal life support within the last six hours. |
Primary Endpoint | Feasibility and adherence, defined as: 1. ≥1 patient enrolled per month per site 2. ≥90% of patients initiated on assigned PEEP strategy within 6 hours of ECLS cannulation 3. ≥90% average protocol adherence across participants |
Design | This domain is an interventional, multicentre, allocation-concealed, open-label RCT. |
Interventions
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Intervention Lead investigators Eligible states Severe acute hypoxemic respiratory failure requiring extracorporeal life support
Description PEEP set to 10 cm H2O (unless increases in PEEP are deemed essential to maintain gas exchange). PEEP will not be modified for spontaneous breathing.
Stage of evaluation Pilot and feasibility RCT Primary endpoint Trial feasibility and protocol adherence
Active comparator N/A
Target sample size 15 Participating sites All sites participating in this domain -
Intervention Lead investigators Eligible states Severe acute hypoxemic respiratory failure requiring extracorporeal life support
Description Positive-end expiratory pressure (PEEP) set to 20 cm H2O while maintaining plateau pressure < 25 cm H2O (during passive ventilation). During assisted / spontaneous breathing, PEEP is adjusted to minimize respiratory effort (assessed by expiratory occlusion pressure, Pocc) while still not exceeding 25 cm H2O.
Stage of evaluation Pilot and feasibility RCT Primary endpoint Trial feasibility and protocol adherence
Active comparator Low PEEP (“PEEP-10”)
Target sample size 15 Participating sites All sites participating in this domain -
Intervention Lead investigators Eligible states Severe acute hypoxemic respiratory failure requiring extracorporeal life support
Description Immediately following randomization and initiation of ECLS, airway opening pressure (AOP) is measured using standard technique. PEEP is then be set at 2 cm H2O above the AOP. AOP is reassessed daily, and PEEP is set based on the daily measurement of AOP. If AOP is >20 cm H2O, PEEP is set to a maximum of 25 cm H2O. If AOP <10 cm H2O, then PEEP is set to 10 cm H2O. During assisted / spontaneous breathing, PEEP is adjusted to minimize respiratory effort (assessed by expiratory occlusion pressure, Pocc) while still not exceeding 25 cm H2O.
Stage of evaluation Pilot and feasibility RCT Primary endpoint Trial feasibility and protocol adherence
Active comparator Low PEEP (“PEEP-10”)
Target sample size 15 Participating sites All sites participating in this domain