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Recruiting NCT04460859

RecruitmEnt Assessed by eleCtRical Impedance Tomography

— Observational Acute Respiratory Distress Syndrome (ARDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Specific lung recruitment maneuvers.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil, Canada, Italy, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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.

Interventions

  • 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

  • Potential for lung recruitment [Time frame: 2 hours]
Secondary outcome measures (6)
  • Recruitment-to-inflation (R/I) ratio [Time frame: 2 hours]
  • EIT-based optimum PEEP level [Time frame: 2 hours]
  • PEEP level resulting in end-expiratory transpulmonary pressure between 0 and 2 cmH2O [Time frame: 2 hours]
  • Organ dysfunction as per the sequential organ failure assessment (SOFA) score [Time frame: Day 1, 3, 7]
  • Vital status at ICU discharge, 28 days, and hospital discharge [Time frame: Through study completion, up to 1 year]
  • Ventilator free days [Time frame: Day 28]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Brazil · 1 center
  • Faculdade de Medicina da University São Paulo — São Paulo
Canada · 1 center
  • St. Michael's Hospital — Toronto
Italy · 1 center
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
Spain · 1 center
  • Vall d'Hebron University Hospital — Barcelona

Publications

  • 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 31577153
  • 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 19255741
  • 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 PMID 27596161
  • 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 Re PMID 37097986
  • 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 36192569
  • 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 33894747

Identifiers

NCT: NCT04460859 · 2027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗