Clinical trial NCT04460859: RecruitmEnt Assessed by eleCtRical Impedance Tomography
Official title: RecruitmEnt Assessed by eleCtRical Impedance Tomography: Feasibility, Correlation With Clinical oUtcomes and pIloT Data on Personalised PEEP Selection.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Keywords: Mechanical Ventilation
Lung recruitment
ARDS
Electrical impedance tomography
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated mechanically ventilated patients will be considered for enrolment in the first week of ARDS diagnosis.

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).

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.

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

Primary outcomes:
measure: Potential for lung recruitment
timeFrame: 2 hours
Secondary outcomes:
measure: Recruitment-to-inflation (R/I) ratio
timeFrame: 2 hours
measure: EIT-based optimum PEEP level
timeFrame: 2 hours
measure: PEEP level resulting in end-expiratory transpulmonary pressure between 0 and 2 cmH2O
timeFrame: 2 hours
measure: Organ dysfunction as per the sequential organ failure assessment (SOFA) score
timeFrame: Day 1, 3, 7
measure: Vital status at ICU discharge, 28 days, and hospital discharge
timeFrame: Through study completion, up to 1 year
measure: Ventilator free days
timeFrame: Day 28
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da University São Paulo
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
Study officials:
affiliation: Unity Health Toronto
name: Laurent Brochard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.