Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study
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 pati...
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2023-03-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Karen J. Bosma |
| collection | DOAJ |
| description | 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. |
| format | Article |
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| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2023-03-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj-art-1291366322d74ccf8cffbc06bb2840852025-01-05T12:45:09ZengBMCTrials1745-62152023-03-0124111810.1186/s13063-023-07163-wStudy protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING studyKaren J. Bosma0Claudio M. Martin1Karen E. A. Burns2Jordi Mancebo Cortes3Juan Carlos Suárez Montero4Yoanna Skrobik5Kevin E. Thorpe6Andre Carlos Kajdacsy-Balla Amaral7Yaseen Arabi8John Basmaji9Gaëtan Beduneau10Francois Beloncle11Guillaume Carteaux12Emmanuel Charbonney13Alexandre Demoule14Martin Dres15Vito Fanelli16Anna Geagea17Ewan Goligher18François Lellouche19Tommaso Maraffi20Alain Mercat21Pablo O. Rodriguez22Jason Shahin23Stephanie Sibley24Savino Spadaro25Katerina Vaporidi26M. Elizabeth Wilcox27Laurent Brochard28On behalf of the Canadian Critical Care Trials Group andthe REVA NetworkDivision of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western OntarioDivision of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western OntarioInterdepartmental Division of Critical Care, University of TorontoIntensive Care Department, Hospital Universitari Sant PauIntensive Care Department, Hospital Universitari Sant PauDepartment of Medicine, McGill UniversityDalla Lana School of Public Health, Biostatistics Division, University of TorontoInterdepartmental Division of Critical Care, University of TorontoIntensive Care Department, King Abdulaziz Medical CityDivision of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western OntarioMedical Intensive Care Unit, Normandie Univ, UNIROUEN, EA 3830, Rouen University HospitalMedical Intensive Care Department, Angers University HospitalService de Médecine Intensive Réanimation, Assistance Publique-Hôpitaux de Paris, CHU Henri Mondor-Albert ChenevierCentre Hospitalier de l’Université de Montréal (CHUM) and Hôpital du Sacré-Coeur de MontréalService de Médecine intensive – Réanimation Département, Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université MédecineService de Médecine intensive – Réanimation Département, Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université MédecineDepartment of Surgical Sciences, University of TurinDivision of Critical Care Medicine, Department of Medicine, North York General HospitalInterdepartmental Division of Critical Care, University of TorontoCentre de recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) – Université LavalIntensive Care Unit, Hôpital Intercommunal de CréteilMedical Intensive Care Department, Angers University HospitalIntensive Care Unit, Instituto Universitario CEMIC (Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”)Department of Critical Care, Division of Pulmonary Medicine, McGill UniversityDepartment of Emergency Medicine and Department of Critical Care Medicine, Queen’s UniversityDepartment of Translational Medicine, Faculty of Medicine and Surgery, University of FerraraUniversity Hospital of HeraklionInterdepartmental Division of Critical Care, University of TorontoInterdepartmental Division of Critical Care, University of TorontoAbstract 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.https://doi.org/10.1186/s13063-023-07163-wProportional assist ventilationWork of breathingWeaning from mechanical ventilationPatient-ventilatory synchronyVentilator-free days |
| spellingShingle | 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 Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study Trials Proportional assist ventilation Work of breathing Weaning from mechanical ventilation Patient-ventilatory synchrony Ventilator-free days |
| title | Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study |
| title_full | Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study |
| title_fullStr | Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study |
| title_full_unstemmed | Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study |
| title_short | Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study |
| title_sort | study protocol for a randomized controlled trial of proportional assist ventilation for minimizing the duration of mechanical ventilation the promizing study |
| topic | Proportional assist ventilation Work of breathing Weaning from mechanical ventilation Patient-ventilatory synchrony Ventilator-free days |
| url | https://doi.org/10.1186/s13063-023-07163-w |
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