Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Bosma Karen J, Martin Claudio M, Burns Karen E A, Mancebo Cortes Jordi, Suárez Montero Juan Carlos, Skrobik Yoanna, Thorpe Kevin E, Amaral Andre Carlos Kajdacsy-Balla, Arabi Yaseen, Basmaji John, Beduneau Gaëtan, Beloncle Francois, Carteaux Guillaume, Charbonney Emmanuel, Demoule Alexandre, Dres Martin, Fanelli Vito, Geagea Anna, Goligher Ewan, Lellouche François, Maraffi Tommaso, Mercat Alain, Rodriguez Pablo O, Shahin Jason, Sibley Stephanie, Spadaro Savino, Vaporidi Katerina, Wilcox M Elizabeth, Brochard Laurent, Canadian Critical Care Trials Group and, REVA Network
Аннотация
METHODS: The objective of this multi-centre randomized controlled trial (RCT) is to determine if, for patients with acute respiratory failure, ventilation with PAV+ will result in a shorter time to successful extubation than with PSV. This multi-centre open-label clinical trial plans to involve approximately 20 sites in several continents. Once eligibility is determined, patients must tolerate a short-term PSV trial and either (1) not meet general weaning criteria or (2) fail a 2-min Zero Continuous Positive Airway Pressure (CPAP) Trial using the rapid shallow breathing index, or (3) fail a spontaneous breathing trial (SBT), in this sequence. Then, participants in this study will be randomized to either PSV or PAV+ in a 1:1 ratio. PAV+ will be set according to a target of muscular pressure. The weaning process will be identical in the two arms. Time to liberation will be the primary outcome; ventilator-free days and other outcomes will be measured.
DISCUSSION: Meta-analyses comparing PAV+ to PSV suggest PAV+ may benefit patients and decrease healthcare costs but no powered study to date has targeted the difficult to wean patient population most likely to benefit from the intervention, or used consistent timing for the implementation of PAV+. Our enrolment strategy, primary outcome measure, and liberation approaches may be useful for studying mechanical ventilation and weaning and can offer important results for patients.
TRIAL REGISTRATION: ClinicalTrials.gov NCT02447692 . Prospectively registered on May 19, 2015.