Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT04460859

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Specific lung recruitment maneuvers

Study Details

Brief summary:

The RECRUIT study is a multinational, multicenter physiological observational study conducted by the PLUG working group. It is a single-day study (1.5-2 hours) associated with specific lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung recruitment in mechanically ventilated patients with ARDS by electrical impedance tomography (EIT).

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Study ID

NCT04460859

Start date

Jun 9, 2020

Status verified date

May, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio <= 200 mmHg)
  • Under continuous sedation with or without paralysis

Exclusion Criteria:

  • Age <18 years
  • Bronchopleural fistula
  • Pure COPD exacerbation
  • Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
  • Hemodynamic instability (Systolic BP < 75 mmHg or MAP < 60 mmHg despite vasopressors and/or heart rate < 55 bpm)
  • Attending physician deems the transient application of high airway pressures to be unsafe

Study Design

Enrollment

171 participants

Anticipated

Interventions and Outcome Measures

Arms

Intubated mechanically ventilated ARDS patients

Intubated mechanically ventilated patients with moderate to severe ARDS according to the Berlin definition

Interventions

Specific lung recruitment maneuvers

Specific lung recruitment maneuvers will be performed to measure the potential for lung recruitment at different levels of positive end-expiratory pressure (PEEP) provided by the mechanical ventilator. Electrical impedance tomography signals, synchronized signals of airway pressure and flow, esophageal pressure (if available), and volumetric capnography (if available) will be recorded continuously, during the time span of the protocol for offline analysis.

Primary outcome measure

  • Potential for lung recruitment [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Laurent Brochard, MD

416-864-5686Laurent.Brochard@unityhealth.to

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1T8

Contacts

Laurent Brochard, MD

416-864-6060Laurent.Brochard@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • Mechanical Ventilation
  • Lung recruitment
  • ARDS
  • Electrical impedance tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2025-05-20.