Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation : the PROMIZING study
Bosma, Karen (London Health Sciences Centre (Canadà))
Martin, Claudio M. (London Health Sciences Centre (Canadà))
Burns, Karen E. A. (Unity Health Toronto - St. Michael's Hospital (Toronto, Canadà))
Mancebo Cortes, Jordi (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Suárez Montero, Juan Carlos (Institut d'Investigació Biomèdica Sant Pau)
Skrobik, Yoanna (McGill University (Montreal, Canadà))
Thorpe, Kevin E. (Li Ka Shing Knowledge Institute of St. Michael's Hospital (Toronto, Canadà))
Kajdacsy-Balla Amaral, Andre Carlos (Sunnybrook Health Sciences Centre (Toronto, Canadà))
Arabi, Y. (King Abdulaziz Medical City (Riad, Aràbia Saudita))
Basmaji, John (London Health Sciences Centre (Canadà))
Beduneau, Gaëtan (Rouen University Hospital (Rouen, França))
Beloncle, François Michel (Angers University Hospital (Angers, França))
Carteaux, Guillaume (CHU Henri Mondor-Albert Chenevier (Creteil, França))
Charbonney, Emmanuel (Centre Hospitalier de l'Université de Montréal and Hôpital du Sacré-Coeur de Montréal (Montreal, Canadà))
Demoule, Alexandre (Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université Médecine (París, França))
Dres, Martin (Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université Médecine (París, França))
Fanelli, Vito (University of Turin (Turí, Itàlia))
Geagea, Anna (North York General Hospital (Toronto, Canadà))
Goligher, Ewan (Toronto General Hospital (Toronto, Canadà))
Lellouche, Francois (Université Laval (Quebec, Canadà))
Maraffi, Tommaso (Hôpital Intercommunal de Créteil (Créteil, França))
Mercat, Alain (Angers University Hospital (Angers, França))
Rodriguez, Pablo O. (Instituto Universitario CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno") (Buenos Aires, Argentina))
Shahin, Jason (McGill University (Quebec, Canadà))
Sibley, Stephanie R. (Queen's University (Kingston, Canadà))
Spadaro, Savino (University of Ferrara (Ferrara, Itàlia))
Vaporidi, Katerina (University Hospital of Heraklion (Heraklion, Grècia))
Wilcox, Mary Elizabeth (University Health Network (Toronto, Canadà))
Brochard, Laurent Jean (Keenan Research Centre (Toronto, Canadà))
Universitat Autònoma de Barcelona

Data:	2023
Resum:	Proportional assist ventilation with load-adjustable gain factors (PAV+) is a mechanical ventilation mode that delivers assistance to breathe in proportion to the patient's effort. The proportional assistance, called the gain, can be adjusted by the clinician to maintain the patient's respiratory effort or workload within a normal range. Short-term and physiological benefits of this mode compared to pressure support ventilation (PSV) include better patient-ventilator synchrony and a more physiological response to changes in ventilatory demand. 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. 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Patient-ventilatory synchrony ; Proportional assist ventilation ; Ventilator-free days ; Weaning from mechanical ventilation ; Work of breathing
Publicat a:	Trials, Vol. 24 Núm. 1 (december 2023) , p. 232, ISSN 1745-6215

DOI: 10.1186/s13063-023-07163-w
PMID: 36973743

18 p, 3.5 MB

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