Recruiting

Ventilation

Sponsor:

Unity Health Toronto

Code:

NCT03963622

Conditions

ARDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Respiratory Mechanics

Standard Ventilation Strategy

Study Details

Brief 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.).

Conditions

ARDS

Study ID

NCT03963622

Start date

Nov 23, 2020

Status verified date

Jan, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 y
2. Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria (Patients who were eligible at the time of screening and whose PaO2/FiO2 became > 200 mm Hg under prone positioning when starting the protocol remained eligible)

Exclusion Criteria:

1. Received continuous mechanical ventilation > 7 days
2. Known or clinically suspected elevated intracranial pressure (>18mmHg) necessitating strict control of PaCO2
3. Known pregnancy
4. Broncho-pleural fistula
5. Severe liver disease (Child-Pugh Score ≥ 10)
6. BMI >40kg/m2
7. Anticipating withdrawal of life support and/or shift to palliation as the goal of care
8. Patient is receiving ECMO at time of randomization

Study Design

Enrollment

740 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

Standard ventilation strategy.

experimental: Respiratory Mechanics

The goal of this arm is to individualize tidal volume (VT) and PEEP according to respiratory mechanics.

Interventions

Respiratory Mechanics

Different maneuvers based on respiratory mechanics will be assessed at the bedside and will be used to individualize ventilator parameters. Recruitability will be assessed with a one breath decremental PEEP maneuver, and search for airway closure with a low-flow pressure volume or pressure-time curve. If the patient has airway closure, the minimal PEEP will be set at the airway opening pressure to avoid closure. If the patient is considered recruitable, the goal is to set PEEP at or above 15cmH20 to maximize alveolar recruitment, until the plateau pressure reaches the safety limit. Volume control ventilation at 6ml·kg-1 will be used.

Once spontaneous breathing has started, the occlusion pressure (P0.1) will be maintained within targets.

Standard Ventilation Strategy

Patients randomized to the control arm will receive standard care. The PEEP is adjusted for oxygenation based on a PEEP-FiO2 table, either the low PEEP-FiO2 or the high PEEP-FiO2 table. Volume targeted ventilation with initial VT 6 mL·kg-1 and Plateau pressure at 30 cmH2O or below, targeting PaO2 60-80 or SpO2 90-95%, adjusted as per the protocol. Pressure-support ventilation is at physician's discretion, but recommended when FiO2 <60%, and is titrated VT 6-8 mL·kg-1.

Primary outcome measure

  • All-cause 60-day mortality [ Time Frame: 60 days ]

Central Contacts and Locations

Central contacts

Laurent Brochard, MD

416-864-6060laurent.brochard@unityhealth.to

Locations

New York University Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

St. Michael's Hospital

Recruiting

Toronto, Canada

Toronto General Hospital

Recruiting

Toronto, Canada

Toronto Western Hospital

Recruiting

Toronto, Canada

More Information

Sponsor

Unity Health Toronto

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Ventilation
  • ARDS
  • Airway closure
  • Lung recruitment
  • COVID-19
  • Basket trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-01-16.