Domain Lead Investigators
Domain Protocol Committee Members
Domain Description
| Objective | The ULTIMATE (PJT 168991) and PROACTIVE (PJT 180592), initially focusing on ultra-protective lung ventilation and early patient awakening and rehabilitation respectively, are being considered for integration. This shift, informed by current literature and the REST trial data (McNamee JJ, Gillies MA, et el. Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypoxemic Respiratory Failure: The REST Randomized Clinical Trial. JAMA. 2021 Sep 21;326(11):1013-1023. PMID: 34463700), suggests that patient outcomes may not significantly differ with changes in lung compliance. Consequently, the project leads propose a unified CO2 removal domain within PRACTICAL Platform, potentially applying ECCO2R to a broader patient group irrespective of elastance with a liberalized P/F ratio of 100-200. The ULTIMATE and PROACTIVE trials maintain distinct scientific approaches and interventions, adhering to their original grant objectives. Each trial continues to address its initial questions without merging or altering their goals. The integration aims solely to enhance efficiency, as both trials target the same study population. |
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| Population | 1. Intubated patients, not on ECLS, with low normalized respiratory elastance (<2.5 cm H2O/(mL/kg predicted body weight)) 2. Intubated patients, not on ECLS, with high normalized respiratory system elastance (≥2.5 cm H2O/(mL/kg predicted body weight)). |
| Primary Endpoint | The primary outcome of this pilot study is feasibility, which includes 3 components; 1. Successful patient recruitment defined as enrolment of 100 AHRF patients from sites over 2 years 2. Adherence to protocol defined as >80% of patients having <20% of monitored values determined to be major protocol deviations 3. Success for lack of crossovers defined as <10% of crossovers between groups (when not allowed by protocol) in either direction |
| Design | An interventional, open-label, randomized, multi-site feasibility study. |
Control Group
| Name | Conventional Lung-Protective Ventilation (LPV) |
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| Description |
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| Target sample size | Approximately 100 evaluable patients will be randomized in this domain protocol. |
| Participating sites | All sites participating in this domain |