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).
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
Enrollment
171
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.
Faculdade de Medicina da University São Paulo
São Paulo, Brazil
RECRUITINGSt. Michael's Hospital
Toronto, Ontario, Canada
RECRUITINGFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
NOT_YET_RECRUITINGPotential 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.
Time frame: 2 hours
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
For those patients with esophageal pressure measurements available
Time frame: 2 hours
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.
Time frame: Day 1, 3, 7
Vital status at ICU discharge, 28 days, and hospital discharge
Vital status (death/alive) will be assessed via chart review
Time frame: Through study completion, up to 1 year
Ventilator free days
Time frame: Day 28
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Vall d'Hebron University Hospital
Barcelona, Spain
RECRUITING