RecruitmEnt Assessed by eleCtRical Impedance Tomography (RECRUIT)
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|ClinicalTrials.gov Identifier: NCT04460859|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment|
|Acute Respiratory Distress Syndrome (ARDS)||Other: Specific lung recruitment maneuvers|
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|
|Estimated Enrollment :||171 participants|
|Official Title:||RecruitmEnt Assessed by eleCtRical Impedance Tomography: Feasibility, Correlation With Clinical oUtcomes and pIloT Data on Personalised PEEP Selection.|
|Actual Study Start Date :||June 9, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
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.
- Potential for lung recruitment [ Time Frame: 2 hours ]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.
- 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 ]For those patients with esophageal pressure measurements available
- Organ dysfunction as per the sequential organ failure assessment (SOFA) score [ Time Frame: Day 1, 3, 7 ]SOFA score min-max: 0-24; a higher score is associated with poor prognosis.
- Vital status at ICU discharge, 28 days, and hospital discharge [ Time Frame: Through study completion, up to 1 year ]Vital status (death/alive) will be assessed via chart review
- Ventilator free days [ Time Frame: Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460859
|Contact: Laurent Brochard, MD||416-864-5686 ext 5686||Laurent.Brochard@unityhealth.to|
|Faculdade de Medicina da University São Paulo||Recruiting|
|São Paulo, Brazil|
|Contact: Marcelo Amato, MD email@example.com|
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5B1T8|
|Contact: Laurent Brochard, MD 416-864-6060 ext 5686 Laurent.Brochard@unityhealth.to|
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico||Not yet recruiting|
|Contact: Tommaso Mauri, MD firstname.lastname@example.org|
|Vall d'Hebron University Hospital||Recruiting|
|Contact: Oriol Roca, MD email@example.com|
|Principal Investigator:||Laurent Brochard, MD||St. Michael's Hospital, Toronto|