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NCT Number: NCT04460859

RecruitmEnt Assessed by eleCtRical Impedance Tomography

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculdade de Medicina da University São Paulo, São Paulo, Brazil

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About this study

Despite higher positive end-expiratory pressure (PEEP) being associated with multiple physiologic benefits, randomized clinical trials comparing higher vs. lower PEEP levels failed to show improved survival of ARDS patients. Higher PEEP should fully exploit its benefits only when implemented in patients with higher potential for alveolar recruitment (i.e., the decrease of non-aerated lung tissue at higher airway pressure) or in patients with airway closure. Retrospective analysis of randomised clinical trials with PEEP suggests that when high PEEP is used in responders (oxygenation), survival may be better. Conversely, in the absence of significant recruitment, higher PEEP should be avoided and lower PEEP might be recommended.

Titration of PEEP provided by the mechanical ventilator in patients with severe lung injury should thus be based on bedside information on lung recruitability. However, no valid method exists to define the best PEEP to optimize recruitment and minimize lung overdistention. Recruitability varies and is often not assessed. Electrical impedance tomography (EIT) is a non-invasive bedside imaging technique for measuring the potential for lung recruitment in ARDS patients. By performing lung (de)recruitment maneuvers and in-depth analyses, we will define lung recruitability indices and develop methods for real-time and personalized PEEP selection. This study will prove the feasibility of minimizing risks associated with inadequate mechanical ventilation by EIT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific lung recruitment maneuvers

Other

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 outcomes

  1. Potential for lung recruitment

    Time frame: 2 hours

    The potential for lung recruitment will be assessed with EIT. Several methods will be used and compared, based on e.g. pixel information of lung aeration, and pressure-volume characteristics at different PEEP steps.

Secondary outcomes

  1. Recruitment-to-inflation (R/I) ratio

    Time frame: 2 hours

  2. EIT-based optimum PEEP level

    Time frame: 2 hours

  3. PEEP level resulting in end-expiratory transpulmonary pressure between 0 and 2 cmH2O

    Time frame: 2 hours

    For those patients with esophageal pressure measurements available

  4. Organ dysfunction as per the sequential organ failure assessment (SOFA) score

    Time frame: Day 1, 3, 7

    SOFA score min-max: 0-24; a higher score is associated with poor prognosis.

  5. Vital status at ICU discharge, 28 days, and hospital discharge

    Time frame: Through study completion, up to 1 year

    Vital status (death/alive) will be assessed via chart review

  6. Ventilator free days

    Time frame: Day 28

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent Brochard, MD

CONTACT

[email protected]

416-864-5686 ext. 5686

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

RecruitmEnt Assessed by eleCtRical Impedance Tomography: Feasibility, Correlation With Clinical oUtcomes and pIloT Data on Personalised PEEP Selection.

Acronym: RECRUIT

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jul 8, 2020
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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