Title {1} | Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study |
Trial registration {2a and 2b}. |
ClinicalTrials.gov Identifier: NCT02447692. https://clinicaltrials.gov/ct2/show/NCT02447692 The protocol is registered on clinicaltrials.gov as NCT02447692, and protocol modifications are shown on clinicaltrials.gov. Additional file 3 shows the main changes which have been made to the protocol and the rationale since the initial registration. All items from the World Health Organization Trial Registration Data Set are included in the trial registry. |
Protocol version {3} | PROMIZING Protocol Version 5.0 – December 1, 2019 |
Funding {4} | This study protocol has been peer reviewed and funded twice by the Canadian Institutes of Health Research (CIHR) through a CIHR Project Grant (2018) and by a CIHR Operating Grant: Industry-partnered Collaborative Research Grant (2014), with Covidien LP, a Medtronic company, as the industry partner. Funding from Covidien LP, a Medtronic company, is provided through the Covidien Investigator Sponsored Research (ISR) Program and subsequently the Medtronic External Research Program (ERP). Covidien LP, a Medtronic company, has also provided in-kind support (loaning of ventilators to sites on an as needed basis to be used only for the purpose of the PROMIZING Study). The funding sources do not have any role in the study design, data collection, analysis, interpretation or publication of manuscript. |
Author details {5a} |
Dr. Karen J. Bosma* Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, and Lawson Health Research Institute, London, Ontario, Canada. KarenJ.Bosma@lhsc.on.ca (Principal author) Dr. Claudio Martin* Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, and Lawson Health Research Institute, London, Ontario, Canada. Claudio.Martin@lhsc.on.ca (Principal author) Dr. Karen E. A Burns Interdepartmental Division of Critical Care, University of Toronto Toronto, Canada and Division of Critical Care, Unity Health Toronto - St. Michael’s Hospital, Toronto, Ontario, Canada. Karen.Burns@unityhealth.to Dr. Jordi Mancebo, Intensive Care Department, Hospital Universitari Sant Pau, Barcelona, Spain; jmancebo@santpau.cat Dr. Juan Carlos Suárez Montero, Intensive Care Department, Hospital Universitari Sant Pau, Barcelona, Spain. jcsmjuan2@gmail.com Dr. Yoanna Skrobik, Department of Medicine, McGill University, Québec, Canada. yoanna.skrobik@mcgill.ca Prof. Kevin E. Thorpe, Dalla Lana School of Public Health, Biostatistics Division, University of Toronto, Applied Health Research Centre, St. Michael’s Hospital, Toronto, Ontario Canada. kevin.thorpe@utoronto.ca Dr. Andre Carlos Kajdacsy-Balla Amaral, Interdepartmental Division of Critical Care, University of Toronto and Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, Ontario, Canada; andrecarlos.amaral@sunnybrook.ca Dr. Yaseen Arabi, Intensive Care Department, King Abdulaziz Medical City, Kingdom of Saudi Arabia. yaseenarabi@yahoo.com Dr. John Basmaji, Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. John.basmaji@lhsc.on.ca Dr. Gaëtan Beduneau, Medical Intensive Care Unit, Normandie Univ, UNIROUEN, EA 3830, Rouen University Hospital, 76000, Rouen, France. gaetan.beduneau@chu-rouen.fr) Dr. Francois Beloncle, Medical Intensive Care Department, Angers University Hospital, Angers, France. francois.beloncle@univ-angers.fr Dr. Guillaume Carteaux, Intensive Medicine Resuscitation Department, Henri Mondor University Hospital, Creteil, France. guillaume.carteaux@aphp.fr Dr. Emmanuel Charbonney, Centre Hospitalier de l’Université de Montréal (CHUM) and Hôpital du Sacré-Coeur de Montréal, Montreal, Québec, Canada; emmanuel.charbonney@umontreal.ca Dr. Alexandre Demoule, Service de Pneumologie, Médecine Intensive et Réanimation, Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université Médecine, Paris, France. alexandre.demoule@aphp.fr Dr. Martin Dres, Service de Médecine intensive – Réanimation Département, Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université Médecine, Paris, France. martin.dres@aphp.fr Dr. Vito Fanelli, Department of Surgical Sciences, University of Turin, Italy. Department of Anaesthesia, Critical Care and Emergency - Città della Salute e della Scienza Hospital – University of Turin, Italy. vito.fanelli@unito.it Dr. Anna Geagea, MD, FRCPC, Division of Critical Care Medicine, Department of Medicine, North York General Hospital, Toronto, Ontario, Canada. Anna.Geagea@nygh.on.ca Dr. Ewan Goligher, Department of Medicine, Toronto General Hospital, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada. Ewan.Goligher@uhn.ca Dr. François Lellouche, Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec City, Québec, Canada. Francois.Lellouche@criucpq.ulaval.ca Dr. Tommaso Maraffi, Intensive Care Unit, Hôpital Intercommunal de Créteil, Créteil, France. Tommaso.Maraffi@chicreteil.fr Dr. Alain Mercat, Medical Intensive Care Department, Angers University Hospital, Angers, France. alain.mercat@univ-angers.fr Dr. Pablo Rodriguez, Center for Medical Education and Clinical Research (CEMIC) “Noberto Quirno”, Department of Medicine, Instituto Universitario CEMIC, Buenos Aires, Argentina. pablorodrig16@gmail.com Dr. Jason Shahin, Department of Critical Care, Division of Pulmonary Medicine, McGill University, Québec, Canada. jason.shahin@gmail.com Dr. Stephanie Sibley, Department of Emergency Medicine and Department of Critical Care Medicine, Queen’s University, Kingston, Ontario, Canada. Stephanie.Sibley@kingstonhsc.ca Dr. Savino Spadaro, Department of Translational Medicine, Faculty of Medicine and Surgery, University of Ferrara, Italy. savinospadaro@gmail.com Dr. Katerina Vaporidi, University Hospital of Heraklion, Voutes, Heraklion, Greece. vaporidi@gmail.com Dr. Elizabeth M. Wilcox, University Health Network and University of Toronto, Toronto, Ontario, Canada. Elizabeth.wilcox@utoronto.ca Dr. Laurent Brochard, MD, Keenan Research Centre, Department of Critical Care, St Michael’s Hospital, Toronto, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada. Laurent.brochard@unityhealth.to (Senior Author) |
Name and contact information for the trial sponsor {5b} |
This is an investigator-sponsored study. The co-principal sponsor-investigators are: Dr. Karen J. Bosma, KarenJ.Bosma@lhsc.on.ca. Dr. Laurent Brochard, Laurent.brochard@unityhealth.to |
Role of sponsor {5c} | The study co-principal sponsor- investigators have ultimate authority in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The study funders do not have any role in the study design, data collection, analysis, interpretation or publication of manuscript. |