Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study
Karen J. Bosma,
Claudio M. Martin,
Karen E. A. Burns,
Jordi Mancebo Cortes,
Juan Carlos Suárez Montero,
Yoanna Skrobik,
Kevin E. Thorpe,
Andre Carlos Kajdacsy-Balla Amaral,
Yaseen Arabi,
John Basmaji,
Gaëtan Beduneau,
Francois Beloncle,
Guillaume Carteaux,
Emmanuel Charbonney,
Alexandre Demoule,
Martin Dres,
Vito Fanelli,
Anna Geagea,
Ewan Goligher,
François Lellouche,
Tommaso Maraffi,
Alain Mercat,
Pablo O. Rodriguez,
Jason Shahin,
Stephanie Sibley,
Savino Spadaro,
Katerina Vaporidi,
M. Elizabeth Wilcox,
Laurent Brochard,
On behalf of the Canadian Critical Care Trials Group and,
the REVA Network
Affiliations
Karen J. Bosma
Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario
Claudio M. Martin
Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario
Karen E. A. Burns
Interdepartmental Division of Critical Care, University of Toronto
Jordi Mancebo Cortes
Intensive Care Department, Hospital Universitari Sant Pau
Juan Carlos Suárez Montero
Intensive Care Department, Hospital Universitari Sant Pau
Yoanna Skrobik
Department of Medicine, McGill University
Kevin E. Thorpe
Dalla Lana School of Public Health, Biostatistics Division, University of Toronto
Andre Carlos Kajdacsy-Balla Amaral
Interdepartmental Division of Critical Care, University of Toronto
Yaseen Arabi
Intensive Care Department, King Abdulaziz Medical City
John Basmaji
Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario
Gaëtan Beduneau
Medical Intensive Care Unit, Normandie Univ, UNIROUEN, EA 3830, Rouen University Hospital
Francois Beloncle
Medical Intensive Care Department, Angers University Hospital
Guillaume Carteaux
Service de Médecine Intensive Réanimation, Assistance Publique-Hôpitaux de Paris, CHU Henri Mondor-Albert Chenevier
Emmanuel Charbonney
Centre Hospitalier de l’Université de Montréal (CHUM) and Hôpital du Sacré-Coeur de Montréal
Alexandre Demoule
Service de Médecine intensive – Réanimation Département, Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université Médecine
Martin Dres
Service de Médecine intensive – Réanimation Département, Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université Médecine
Vito Fanelli
Department of Surgical Sciences, University of Turin
Anna Geagea
Division of Critical Care Medicine, Department of Medicine, North York General Hospital
Ewan Goligher
Interdepartmental Division of Critical Care, University of Toronto
François Lellouche
Centre de recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) – Université Laval
Tommaso Maraffi
Intensive Care Unit, Hôpital Intercommunal de Créteil
Alain Mercat
Medical Intensive Care Department, Angers University Hospital
Pablo O. Rodriguez
Intensive Care Unit, Instituto Universitario CEMIC (Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”)
Jason Shahin
Department of Critical Care, Division of Pulmonary Medicine, McGill University
Stephanie Sibley
Department of Emergency Medicine and Department of Critical Care Medicine, Queen’s University
Savino Spadaro
Department of Translational Medicine, Faculty of Medicine and Surgery, University of Ferrara
Katerina Vaporidi
University Hospital of Heraklion
M. Elizabeth Wilcox
Interdepartmental Division of Critical Care, University of Toronto
Laurent Brochard
Interdepartmental Division of Critical Care, University of Toronto
On behalf of the Canadian Critical Care Trials Group and
Abstract Background 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. 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.
