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Platform of Randomized Adaptive Clinical Trials in Critical Illness
NCT05440851 · View on ClinicalTrials.gov ↗
Study 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 range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elastance, requiring extracorporeal life support) and across a range of investigational phases (i.e., preliminary mechanistic trials, full-scale clinical trials). AHRF is a common and life-threatening clinical syndrome affecting millions globally every year. Patients with AHRF are at high risk of death and long-term morbidity. Patients who require invasive mechanical ventilation are at risk of ventilator-induced lung injury and ventilator-induced diaphragm dysfunction. New treatments and treatment strategies are needed to improve outcomes for these very ill patients. Utilizing advances in Bayesian adaptive trial design, the platform will facilitate efficient yet rigorous testing of new treatments for AHRF, with a particular focus on mechanical ventilation strategies and extracorporeal life support techniques as well as pharmacological agents and new medical devices. The platform is designed to enable evaluation of novel interventions at a variety of stages of investigation, including pilot and feasibility trials, trials focused on mechanistic surrogate endpoints for preliminary clinical evaluation, and full-scale clinical trials assessing the impact of interventions on patient-centered outcomes. Interventions will be evaluated within therapeutic domains. A domain is defined as a set of interventions that are intended to act on specific mechanisms of injury using different variations of a common therapeutic strategy. Domains are intended to function independently of each other, allowing independent evaluation of multiple therapies within the same patient. Once feasibility is established, Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at
Conditions Studied
Interventions
- OTHER Ultra-Protective Ventilation Facilitated by Extracorporeal Support
- OTHER Lung-Protective Ventilation (LPV)
- OTHER Driving Pressure-Limited Ventilation (DPL)
- OTHER Lung- and Diaphragm-Protective Ventilation and Sedation (LDPVS)
- DRUG Early Cohort corticosteroid dose
Study Locations (20)
California
- University of California Los Angeles (UCLA) — Los Angeles
- University of San Diego (UCSD) — San Diego
- University of California San Francisco — San Francisco
Maryland
- University of Maryland Medical System — Baltimore
- The Johns Hopkins Medicine — Baltimore
Michigan
- VA Ann Arbor Healthcare System — Ann Arbor
- University of Michigan Health — Ann Arbor
New York
- Mount Sinai New York City — New York
- Columbia University Irving Medical Center — New York
Ohio
- University of Cincinnati College of Medicine — Cincinnati
- Cleveland Clinic — Cleveland
Pennsylvania
- University of Pennsylvania — Philadelphia
- Thomas Jefferson University Hospital — Philadelphia
Arizona
- University of Arizona — Tucson
Colorado
- University of Colorado Hospital — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,250 participants |
| Start Date | 2023-04-30 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05440851
The ClinicalTrials.gov registry entry for NCT05440851 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Health Network, Toronto, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Respiratory Insufficiency appearing as the primary indexed condition, and to 5 interventions — of which Ultra-Protective Ventilation Facilitated by Extracorporeal Support is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05440851 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Maryland, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05440851 about?
NCT05440851 is a clinical study titled "Platform of Randomized Adaptive Clinical Trials in Critical Illness". 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 range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elas...
What is the current status of trial NCT05440851?
This trial is currently recruiting. It is a NA study. The enrollment target is 6,250 participants. The study started on 2023-04-30. Estimated completion is 2027-03-31.
What conditions does trial NCT05440851 study?
This clinical trial studies the following conditions: Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication, Mechanical Ventilation Pressure High. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05440851?
The interventions under investigation include: Ultra-Protective Ventilation Facilitated by Extracorporeal Support (OTHER), Lung-Protective Ventilation (LPV) (OTHER), Driving Pressure-Limited Ventilation (DPL) (OTHER), Lung- and Diaphragm-Protective Ventilation and Sedation (LDPVS) (OTHER), Early Cohort corticosteroid dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05440851?
This trial is sponsored by University Health Network, Toronto, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05440851 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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