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RecruitmEnt Assessed by eleCtRical Impedance Tomography (RECRUIT)

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ClinicalTrials.gov Identifier: NCT04460859
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, 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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04460859


Contacts
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Contact: Laurent Brochard, MD 416-864-5686 ext 5686 Laurent.Brochard@unityhealth.to

Locations
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Brazil
Faculdade de Medicina da University São Paulo Recruiting
São Paulo, Brazil
Contact: Marcelo Amato, MD       marcelo.amato@fm.usp.br   
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1T8
Contact: Laurent Brochard, MD    416-864-6060 ext 5686    Laurent.Brochard@unityhealth.to   
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Not yet recruiting
Milan, Italy
Contact: Tommaso Mauri, MD       tommaso.mauri@unimi.it   
Spain
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain
Contact: Oriol Roca, MD       oroca@vhebron.net   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Laurent Brochard, MD St. Michael's Hospital, Toronto
Additional Information:
Publications:
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT04460859    
Other Study ID Numbers: 2027
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
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 St. Michael's Hospital, Toronto:
Mechanical Ventilation
Lung recruitment
ARDS
Electrical impedance tomography
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury