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NCT03963622 · ClinicalTrials.gov registry record · NA
Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
A NA study of ARDS, sponsored by Unity Health Toronto.
- Recruiting
- Registry status
- NA
- Development phase
- 740
- Enrollment target
- 20
- Study locations
NCT03963622: Recruiting NA study of ARDS, sponsored by Unity Health Toronto.
NCT03963622 is a NA study of ARDS that is actively recruiting participants, run by Unity Health Toronto. The registered enrollment target is 740 participants, above the 534-participant average among 14 other ARDS trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03963622, a NA study of ARDS, is actively recruiting participants, sponsored by Unity Health Toronto.
- RECRUITING
- Registry status
- NA
- Development phase
- 740 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS). The CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations. CAVIARDS consists of an identical 2-arm mechanical ventilation protocol implemented in two different study populations (COVID-19 and non-COVID-19 patients). As per a typical basket trial design, the operational structure of both the COVID-19 substudy (CAVIARDS-19) and non-COVID-19 substudy (CAVIARDS-all) is shared (recruitment, procedures, data collection, analysis, management, etc.).
Primary Outcome
The lack of an appropriate surrogate endpoint, and the high baseline mortality rate mandate a multicentre RCT to determine the mortality effects of setting the ventilator based on recruitability and effort compared with conventional ventilation.
Conditions Studied
Interventions
- OTHER Respiratory Mechanics
- OTHER Standard Ventilation Strategy
Study Locations (20)
Other
- Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC) - Buenos Aires
- Complejo Médico Policía Federal Argentina Churruca Visca - Buenos Aires
- Hospital Británico de Buenos Aires - Buenos Aires
- Sanatorio Anchorena Recoleta - Buenos Aires
- Sanatorio Mater Dei - Buenos Aires
- Sanatorio Anchorena San Martín - San Martín
- St. Michael's Hospital - Toronto
- Toronto General Hospital - Toronto
- Toronto Western Hospital - Toronto
- Pontificia Universidad Católica de Chile - Santiago
- CHU Amiens-Picardie - Amiens
- Centre hospitalier universitaire d'Angers - Angers
- CH Victor Dupouy - Argenteuil
- CH de Beauvais - Beauvais
- CHU Bordeaux - Haut Leveque - Bordeaux
- Hopital de la Cavale Blanche - CHRU Brest - Brest
- CH de Cholet - Cholet
- Hopital Intercommunal de Creteil - Créteil
- CHU Grenoble-Alpes - Grenoble
New York
- New York University Grossman School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 740 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT03963622 shows while recruiting
NCT03963622 is an interventional study that assigns participants to a tested intervention. The registered 740 participants enrollment target is mid-sized for trials with a published cap, above the 534-participant average among 14 other ARDS trials with a reported enrollment target (39% higher).
The record links to 1 condition, with ARDS appearing as the primary indexed condition, and to 2 interventions - of which Respiratory Mechanics is the first listed.
NCT03963622 names 20 study sites across 2 states, led by Other, New York.
Frequently Asked Questions
What is clinical trial NCT03963622 about?
NCT03963622 is a clinical study titled "Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)". This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS). The ...
What is the current status of trial NCT03963622?
This trial is currently recruiting. It is a NA study. The enrollment target is 740 participants. The study started on 2020-11-23. Estimated completion is 2026-09.
What conditions does trial NCT03963622 study?
This clinical trial studies the following conditions: ARDS.
What interventions are being tested in trial NCT03963622?
The interventions under investigation include: Respiratory Mechanics (OTHER), Standard Ventilation Strategy (OTHER).
Who is sponsoring clinical trial NCT03963622?
This trial is sponsored by Unity Health Toronto, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03963622 being conducted?
This trial has 20 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ARDS
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03963622's enrollment target sits among peer trials
740 4th of 14 higher than 11 of 14 other ARDS trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ARDS trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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