NCT04460859

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jun 2020Jun 2027

Study Start

First participant enrolled

June 9, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

6.5 years

First QC Date

June 29, 2020

Last Update Submit

May 15, 2025

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

Mechanical VentilationLung recruitmentARDSElectrical impedance tomography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    2 hours

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

    Day 1, 3, 7

  • Vital status at ICU discharge, 28 days, and hospital discharge

    Through study completion, up to 1 year

  • +1 more secondary outcomes

Study Arms (1)

Intubated mechanically ventilated ARDS patients

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

Other: Specific lung recruitment maneuvers

Interventions

Specific lung recruitment maneuversOTHER

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.

Intubated mechanically ventilated ARDS patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intubated mechanically ventilated patients will be considered for enrolment in the first week of ARDS diagnosis.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Faculdade de Medicina da University São Paulo

São Paulo, Brazil

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B1T8, Canada

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

NOT YET RECRUITING

Vall d'Hebron University Hospital

Barcelona, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 31577153BACKGROUND

  • 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.

    PMID: 19255741BACKGROUND

  • 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.

    PMID: 27596161BACKGROUND

  • Jonkman AH, Alcala GC, Pavlovsky B, Roca O, Spadaro S, Scaramuzzo G, Chen L, Dianti J, Sousa MLA, Sklar MC, Piraino T, Ge H, Chen GQ, Zhou JX, Li J, Goligher EC, Costa E, Mancebo J, Mauri T, Amato M, Brochard LJ; Pleural Pressure Working Group (PLUG). Lung Recruitment Assessed by Electrical Impedance Tomography (RECRUIT): A Multicenter Study of COVID-19 Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2023 Jul 1;208(1):25-38. doi: 10.1164/rccm.202212-2300OC.

    PMID: 37097986DERIVED

  • 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.

    PMID: 36192569DERIVED

  • 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.

    PMID: 33894747DERIVED

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Laurent Brochard, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Brochard, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 8, 2020

Study Start

June 9, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 20, 2025

Record last verified: 2025-05

Locations

ES(1)BR(1)IT(1)CA(1)