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RecruitmEnt Assessed by eleCtRical Impedance Tomography (RECRUIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04460859
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : September 30, 2021
Information provided by (Responsible Party):
Unity Health Toronto

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).

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome (ARDS) Other: Specific lung recruitment maneuvers

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 171 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: RecruitmEnt Assessed by eleCtRical Impedance Tomography: Feasibility, Correlation With Clinical oUtcomes and pIloT Data on Personalised PEEP Selection.
Actual Study Start Date : June 9, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Group/Cohort Intervention/treatment
Intubated mechanically ventilated ARDS patients
Intubated mechanically ventilated patients with moderate to severe ARDS according to the Berlin definition
Other: 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 Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intubated mechanically ventilated patients will be considered for enrolment in the first week of ARDS diagnosis.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04460859

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Contact: Laurent Brochard, MD 416-864-5686 ext 5686

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Faculdade de Medicina da University São Paulo Recruiting
São Paulo, Brazil
Contact: Marcelo Amato, MD   
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1T8
Contact: Laurent Brochard, MD    416-864-6060 ext 5686   
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Not yet recruiting
Milan, Italy
Contact: Tommaso Mauri, MD   
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain
Contact: Oriol Roca, MD   
Sponsors and Collaborators
Unity Health Toronto
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Principal Investigator: Laurent Brochard, MD Unity Health Toronto
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Unity Health Toronto Identifier: NCT04460859    
Other Study ID Numbers: 2027
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Health Toronto:
Mechanical Ventilation
Lung recruitment
Electrical impedance tomography
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury