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; Canadian Critical Care Trials Group and; REVA Network

doi:10.1186/s13063-023-07163-w

Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study

Trials. 2023 Mar 27;24(1):232. doi: 10.1186/s13063-023-07163-w.

Authors

Karen J Bosma^#^{1

2}, Claudio M Martin^#^{3

4}, Karen E A Burns^{5

6}, Jordi Mancebo Cortes⁷, Juan Carlos Suárez Montero⁷, Yoanna Skrobik⁸, Kevin E Thorpe^{9

10}, Andre Carlos Kajdacsy-Balla Amaral^{5

11}, Yaseen Arabi¹², John Basmaji^{3

4}, Gaëtan Beduneau¹³, Francois Beloncle¹⁴, Guillaume Carteaux¹⁵, Emmanuel Charbonney¹⁶, Alexandre Demoule¹⁷, Martin Dres¹⁷, Vito Fanelli^{18

19}, Anna Geagea²⁰, Ewan Goligher^{5

21}, François Lellouche²², Tommaso Maraffi²³, Alain Mercat¹⁴, Pablo O Rodriguez²⁴, Jason Shahin²⁵, Stephanie Sibley²⁶, Savino Spadaro²⁷, Katerina Vaporidi²⁸, M Elizabeth Wilcox^{5

29}, Laurent Brochard^{5

30}; Canadian Critical Care Trials Group and; REVA Network

Affiliations

¹ Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada. KarenJ.Bosma@lhsc.on.ca.
² Lawson Health Research Institute, London Health Sciences Centre, London, ON, Canada. KarenJ.Bosma@lhsc.on.ca.
³ Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada.
⁴ Lawson Health Research Institute, London Health Sciences Centre, London, ON, Canada.
⁵ Interdepartmental Division of Critical Care, University of Toronto, Toronto, ON, Canada.
⁶ Division of Critical Care, Unity Health Toronto - St. Michael's Hospital, Toronto, ON, Canada.
⁷ Intensive Care Department, Hospital Universitari Sant Pau, Barcelona, Spain.
⁸ Department of Medicine, McGill University, Québec, Canada.
⁹ Dalla Lana School of Public Health, Biostatistics Division, University of Toronto, Toronto, ON, Canada.
¹⁰ Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada.
¹¹ Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON, Canada.
¹² Intensive Care Department, King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia.
¹³ Medical Intensive Care Unit, Normandie Univ, UNIROUEN, EA 3830, Rouen University Hospital, 76000, Rouen, France.
¹⁴ Medical Intensive Care Department, Angers University Hospital, Angers, France.
¹⁵ Service de Médecine Intensive Réanimation, Assistance Publique-Hôpitaux de Paris, CHU Henri Mondor-Albert Chenevier, Creteil, France.
¹⁶ Centre Hospitalier de l'Université de Montréal (CHUM) and Hôpital du Sacré-Coeur de Montréal, Montreal, QC, Canada.
¹⁷ Service de Médecine intensive - Réanimation Département, Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université Médecine, Paris, France.
¹⁸ Department of Surgical Sciences, University of Turin, Turin, Italy.
¹⁹ Department of Anaesthesia, Critical Care and Emergency - Città della Salute e della Scienza Hospital - University of Turin, Turin, Italy.
²⁰ Division of Critical Care Medicine, Department of Medicine, North York General Hospital, Toronto, ON, Canada.
²¹ Department of Medicine, Toronto General Hospital, Toronto, ON, Canada.
²² Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) - Université Laval, Québec City, QC, Canada.
²³ Intensive Care Unit, Hôpital Intercommunal de Créteil, Créteil, France.
²⁴ Intensive Care Unit, Instituto Universitario CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"), Av. Cnel. Diaz 2423 3rd floor, Buenos Aires, Argentina.
²⁵ Department of Critical Care, Division of Pulmonary Medicine, McGill University, Québec, Canada.
²⁶ Department of Emergency Medicine and Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.
²⁷ Department of Translational Medicine, Faculty of Medicine and Surgery, University of Ferrara, Ferrara, Italy.
²⁸ University Hospital of Heraklion, Voutes, Heraklion, Greece.
²⁹ University Health Network , Toronto, ON, Canada.
³⁰ Keenan Research Centre, Department of Critical Care, St Michael's Hospital, Unity Health Toronto, Toronto, Canada.

^# Contributed equally.

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.

Keywords: Patient-ventilatory synchrony; Proportional assist ventilation; Ventilator-free days; Weaning from mechanical ventilation; Work of breathing.

Publication types

Clinical Trial Protocol

MeSH terms

Humans
Interactive Ventilatory Support* / adverse effects
Multicenter Studies as Topic
Positive-Pressure Respiration / methods
Randomized Controlled Trials as Topic
Respiration
Respiration, Artificial* / adverse effects
Respiration, Artificial* / methods
Ventilator Weaning / methods

Associated data

ClinicalTrials.gov/NCT02447692

Abstract

Publication types

MeSH terms

Associated data

Grants and funding