Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)

Part of paid clinical trials in New York, New York.

Sponsor
Unity Health Toronto
Study ID
NCT03963622
Status
Recruiting
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Conditions

  • ARDS

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Respiratory Mechanics — OTHER
    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 — OTHER
    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.

Study Details

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.).

Key Dates

Start date
Nov 23, 2020
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
740 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York University Grossman School of MedicineNew YorkNew York10016
David Kaufman, MD

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New York University Grossman School of Medicine· New York, NY

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