Domain Description
Objective | The primary objective of the full PROACTIVE trial will be to determine the efficacy of a VV ECMO-facilitated strategy of awakening with early extubation and rehabilitation vs. conventional MV on days alive and out of hospital at Day 60. Feasibility objectives of the PROACTIVE Pilot RCT are to assess:
This pilot RCT will determine the feasibility that a RCT of VV ECMO can be conducted successfully and the degree to which the intervention can markedly reduce sedation, neuromuscular blockade, and immobility during mechanical ventilation in patients with ARDS. If feasibility is demonstrated, investigators will remain blinded to these clinical results and the 60 pilot RCT patients will roll over into the full PROACTIVE trial. |
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Population | This domain will enroll patients receiving invasive mechanical ventilation for early acute hypoxemic respiratory failure (PaO2:FiO2 < 300 mm Hg, <72 hours) in low elastance state. |
Primary Endpoint | The primary outcome of this pilot study is feasibility. |
Design | The PROACTIVE pilot trial is a multi-centre, randomized, open-label trial, embedded as a domain within the PRACTICAL platform trial. The patient population for this domain includes intubated patients who are not on extracorporeal life support and have been diagnosed with acute hypoxemic respiratory failure characterized by low lung elastance. This trial will be conducted in compliance with protocol and GCP guidelines. Consenting eligible patients will be randomized to either the interventional strategy or the control ventilation strategy. Patients in the experimental group will receive the control ventilation strategy along with VV ECMO to facilitate earlier awakening, ventilator liberation, and rehabilitation. The control group will receive the usual standard of care ventilation. If the patient’s clinical status declines and meets the ECMO criteria for ventilation (as established by prior randomized clinical trials), they would be eligible to receive ECMO if their treating physician deemed that appropriate. Study procedures common to both groups will continue for the duration of the ICU stay up to day 30. We will collect daily data during mechanical ventilation until day 30. Thereafter, we will follow patients to the time of hospital discharge and record ICU/hospital survival. We will also assess health related quality of life by telephone interview or via email 6 months after randomization. |
Control Group
Name | Conventional lung-protective ventilation (LPV) |
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Description |
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Target sample size | 30 patients |
Participating sites | All sites participating in this domain |
Interventions
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Intervention Lead investigators Eligible states Low elastance (invasively ventilated) Description - VV ECMO via single access, dual-lumen Protek Duo cannula
- Tidal volume target of 6 mL/kg predicted body weight
- Plateau airway pressure <30 cm H2O
Stage of evaluation Phase II Primary endpoint Feasibility Active comparator Conventional lung-proteective ventilation Target sample size 30 patients Participating sites All sites participating in this domain