Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: Study protocol for a pilot randomized controlled trial, the PROTECTION trial

for the Protection Study Group

Research output: Contribution to journalArticle

Abstract

Background: Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods: PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmH2O. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubation. The primary endpoint of the study will be to verify the feasibility of PSV + sigh evaluated through reduction of failure to remain on assisted ventilation during the first 28 days in the PSV + sigh group versus standard PSV (15 vs. 22%). Failure will be defined by switch back to controlled ventilation for more than 24 h or use of rescue treatments or reintubation within 48 h from elective extubation. Setting the power to 80% and first-risk order to 5%, the computed size of the trial is 129 patients per arm. Discussion: PROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days. Trial registration: ClinicalTrials.gov, NCT03201263. Registered on 28 June 2017.

Original languageEnglish
Article number460
JournalTrials
Volume19
Issue number1
DOIs
Publication statusPublished - Aug 29 2018

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Respiratory Insufficiency
Ventilation
Randomized Controlled Trials
Pressure
Intensive Care Units
Lung
Economic Inflation
Lung Injury
Mechanical Ventilators
Weaning

Keywords

  • Intervention study
  • Mechanical ventilation
  • Positive-pressure ventilation
  • Pressure support
  • Recruitment
  • Sigh
  • Ventilator-induced lung injury
  • Weaning

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients : Study protocol for a pilot randomized controlled trial, the PROTECTION trial. / for the Protection Study Group.

In: Trials, Vol. 19, No. 1, 460, 29.08.2018.

Research output: Contribution to journalArticle

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abstract = "Background: Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods: PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmH2O. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubation. The primary endpoint of the study will be to verify the feasibility of PSV + sigh evaluated through reduction of failure to remain on assisted ventilation during the first 28 days in the PSV + sigh group versus standard PSV (15 vs. 22{\%}). Failure will be defined by switch back to controlled ventilation for more than 24 h or use of rescue treatments or reintubation within 48 h from elective extubation. Setting the power to 80{\%} and first-risk order to 5{\%}, the computed size of the trial is 129 patients per arm. Discussion: PROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days. Trial registration: ClinicalTrials.gov, NCT03201263. Registered on 28 June 2017.",
keywords = "Intervention study, Mechanical ventilation, Positive-pressure ventilation, Pressure support, Recruitment, Sigh, Ventilator-induced lung injury, Weaning",
author = "{for the Protection Study Group} and Tommaso Mauri and Giuseppe Foti and Carla Fornari and Constantin, {Jean Michel} and Claude Guerin and Paolo Pelosi and Marco Ranieri and Sara Conti and Daniela Tubiolo and Egle Rondelli and Federica Lovisari and Tommaso Fossali and Savino Spadaro and Grieco, {Domenico Luca} and Paolo Navalesi and Italo Calamai and Tobias Becher and Oriol Roca and Wang, {Yu Mei} and Rihard Knafelj and Andrea Cortegiani and Jordi Mancebo and Laurent Brochard and Antonio Pesenti and Giacomo Grasselli and Elena Spinelli and Chiara Abbruzzese and Roberto Rona and Alfio Bronco and Silvia Villa and Stefano Gianni and Alessandra Papoff and Riccardo Pinciroli and Riccardo Colombo and Chiara Sproccati and Pietro Mandelli and Federico Villa and Nicolo' Patroniti and Iole Brunetti and Lorenzo Ball and Volta, {Carlo Alberto} and Marta Lazzeri and Elisabetta Maragoni and Davide Eleuteri and Giuseppe Bello and Antonio dell'Anna and Eugenio Garofalo and Andrea Bruni and Eugenio Biamonte and Rocco D'Andrea",
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T1 - Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients

T2 - Study protocol for a pilot randomized controlled trial, the PROTECTION trial

AU - for the Protection Study Group

AU - Mauri, Tommaso

AU - Foti, Giuseppe

AU - Fornari, Carla

AU - Constantin, Jean Michel

AU - Guerin, Claude

AU - Pelosi, Paolo

AU - Ranieri, Marco

AU - Conti, Sara

AU - Tubiolo, Daniela

AU - Rondelli, Egle

AU - Lovisari, Federica

AU - Fossali, Tommaso

AU - Spadaro, Savino

AU - Grieco, Domenico Luca

AU - Navalesi, Paolo

AU - Calamai, Italo

AU - Becher, Tobias

AU - Roca, Oriol

AU - Wang, Yu Mei

AU - Knafelj, Rihard

AU - Cortegiani, Andrea

AU - Mancebo, Jordi

AU - Brochard, Laurent

AU - Pesenti, Antonio

AU - Grasselli, Giacomo

AU - Spinelli, Elena

AU - Abbruzzese, Chiara

AU - Rona, Roberto

AU - Bronco, Alfio

AU - Villa, Silvia

AU - Gianni, Stefano

AU - Papoff, Alessandra

AU - Pinciroli, Riccardo

AU - Colombo, Riccardo

AU - Sproccati, Chiara

AU - Mandelli, Pietro

AU - Villa, Federico

AU - Patroniti, Nicolo'

AU - Brunetti, Iole

AU - Ball, Lorenzo

AU - Volta, Carlo Alberto

AU - Lazzeri, Marta

AU - Maragoni, Elisabetta

AU - Eleuteri, Davide

AU - Bello, Giuseppe

AU - dell'Anna, Antonio

AU - Garofalo, Eugenio

AU - Bruni, Andrea

AU - Biamonte, Eugenio

AU - D'Andrea, Rocco

PY - 2018/8/29

Y1 - 2018/8/29

N2 - Background: Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods: PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmH2O. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubation. The primary endpoint of the study will be to verify the feasibility of PSV + sigh evaluated through reduction of failure to remain on assisted ventilation during the first 28 days in the PSV + sigh group versus standard PSV (15 vs. 22%). Failure will be defined by switch back to controlled ventilation for more than 24 h or use of rescue treatments or reintubation within 48 h from elective extubation. Setting the power to 80% and first-risk order to 5%, the computed size of the trial is 129 patients per arm. Discussion: PROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days. Trial registration: ClinicalTrials.gov, NCT03201263. Registered on 28 June 2017.

AB - Background: Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods: PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmH2O. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubation. The primary endpoint of the study will be to verify the feasibility of PSV + sigh evaluated through reduction of failure to remain on assisted ventilation during the first 28 days in the PSV + sigh group versus standard PSV (15 vs. 22%). Failure will be defined by switch back to controlled ventilation for more than 24 h or use of rescue treatments or reintubation within 48 h from elective extubation. Setting the power to 80% and first-risk order to 5%, the computed size of the trial is 129 patients per arm. Discussion: PROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days. Trial registration: ClinicalTrials.gov, NCT03201263. Registered on 28 June 2017.

KW - Intervention study

KW - Mechanical ventilation

KW - Positive-pressure ventilation

KW - Pressure support

KW - Recruitment

KW - Sigh

KW - Ventilator-induced lung injury

KW - Weaning

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