Status:
RECRUITING
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Lead Sponsor:
University Health Network, Toronto
Conditions:
Respiratory Insufficiency
Extracorporeal Membrane Oxygenation Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a r...
Detailed Description
EXPAND-ECLS domain: The EXPAND-ECLS pilot trial is a multi-center, randomized, open-label, feasibility trial, embedded as a domain within the PRACTICAL platform trial. The ULTIMATE arm of this domain ...
Eligibility Criteria
Inclusion
- PRACTICAL Platform
- Acute hypoxemic respiratory failure meeting all of the following criteria;
- New or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support
- Receiving any of the following types of oxygen or respiratory support for at least 4 hours prior to the time of randomization; supplemental oxygen at 10 L/min or higher, high flow nasal oxygen (at any flow rate), invasive ventilator support, extra-corporeal life support (ECLS), or non-invasive ventilator support
- Minimum FiO2 ≥ 0.40 (for venturi mask, high flow nasal cannula, or invasive or non-invasive ventilation) or oxygen flow rate ≥10 L/min on face mask for at least 4 hours at the time of evaluation for eligibility unless already on extra-corporeal life support
- Age ≥ 18 years
- Hypoxemia not primarily attributable to acute heart failure, fluid overload, or pulmonary embolism (PE)
- PRACTICAL Platform
Exclusion
- Extubation is planned or anticipated on the day of screening
- ICU discharged is planned or anticipated on the day of screening
- If the patient is moribund and deemed unlikely to survive 24 hours (as determined by the clinical team)
- If the patient is being transitioned to a fully palliative philosophy of care
- EXPAND-ECLS Domain Inclusion Criteria:
- Receiving invasive Endotracheal mechanical ventilation for ≤ 72 hours.5 days
- Early Moderate-severe hypoxemic respiratory failure with a PaO2/FiO2≤150200 mmHg for at least 6 hours
- EXPAND-ECLS Domain
Key Trial Info
Start Date :
April 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
6250 Patients enrolled
Trial Details
Trial ID
NCT05440851
Start Date
April 30 2023
End Date
March 31 2027
Last Update
November 17 2025
Active Locations (80)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
3
University of San Diego (UCSD)
San Diego, California, United States, 92121
4
University of Colorado Hospital
Aurora, Colorado, United States, 80045