RecruitmEnt Assessed by eleCtRical Impedance Tomography (RECRUIT)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome (ARDS)
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 171

Contacts and Locations

• Study Contact: Name: Laurent Brochard, MD; Phone Number: 5686 416-864-5686; Email: Laurent.Brochard@unityhealth.to

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • Faculdade de Medicina da University São Paulo
    • Contact: Marcelo Amato, MD; Email: marcelo.amato@fm.usp.br
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1T8
      • Recruiting
      • St. Michael's Hospital
      • Contact: Laurent Brochard, MD; Phone Number: 5686 416-864-6060; Email: laurent.brochard@unityhealth.to
• Italy
  • Milan, Italy
    • Not yet recruiting
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    • Contact: Tommaso Mauri, MD; Email: tommaso.mauri@unimi.it
• Spain
  • Barcelona, Spain
    • Recruiting
    • Vall d'Hebron University Hospital
    • Contact: Oriol Roca, MD; Email: oroca@vhebron.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential for lung recruitment	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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator free days		Day 28
Recruitment-to-inflation (R/I) ratio		2 hours
EIT-based optimum PEEP level		2 hours
PEEP level resulting in end-expiratory transpulmonary pressure between 0 and 2 cmH2O	For those patients with esophageal pressure measurements available	2 hours
Organ dysfunction as per the sequential organ failure assessment (SOFA) score	SOFA score min-max: 0-24; a higher score is associated with poor prognosis.	Day 1, 3, 7
Vital status at ICU discharge, 28 days, and hospital discharge	Vital status (death/alive) will be assessed via chart review	Through study completion, up to 1 year

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Laurent Brochard, MD, Unity Health Toronto

Publications and helpful links

General Publications

• Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
• Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
• Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
• Otahal M, Mlcek M, Borges JB, Alcala GC, Hladik D, Kuriscak E, Tejkl L, Amato M, Kittnar O. Prone positioning may increase lung overdistension in COVID-19-induced ARDS. Sci Rep. 2022 Oct 3;12(1):16528. doi: 10.1038/s41598-022-20881-6.
• Mlcek M, Otahal M, Borges JB, Alcala GC, Hladik D, Kuriscak E, Tejkl L, Amato M, Kittnar O. Targeted lateral positioning decreases lung collapse and overdistension in COVID-19-associated ARDS. BMC Pulm Med. 2021 Apr 24;21(1):133. doi: 10.1186/s12890-021-01501-x.

Helpful Links

• Website of the PLUG working group

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ARDS; Mechanical Ventilation; Electrical impedance tomography; Lung recruitment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No