RecruitmEnt Assessed by eleCtRical Impedance Tomography

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

— RECRUIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460859
• Other study ID #: 2027
• Status: Recruiting
• Start date: June 9, 2020
• Est. completion date: June 2022

Study information

• Verified date: September 2021
• Source: Unity Health Toronto
• Contact: Laurent Brochard, MD
• Phone: 416-864-5686
• Email: Laurent.Brochard[@]unityhealth.to
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 171
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina da University São Paulo	São Paulo
Canada	St. Michael's Hospital	Toronto	Ontario
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan
Spain	Vall d'Hebron University Hospital	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Countries where clinical trial is conducted

Brazil,  Canada,  Italy,  Spain, 

References & Publications (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. — View 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. — View Citation

Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Böhm 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment-to-inflation (R/I) ratio		2 hours
Secondary	EIT-based optimum PEEP level		2 hours
Secondary	PEEP level resulting in end-expiratory transpulmonary pressure between 0 and 2 cmH2O	For those patients with esophageal pressure measurements available	2 hours
Secondary	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
Secondary	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
Secondary	Ventilator free days		Day 28

External Links

•   Website of the PLUG working group