Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial

It is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to...

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Autores: Morales-Quinteros, Luis|||0000-0002-8937-9824, Schultz, Marcus J.|||0000-0003-3969-7792, Serpa-Neto, Ary, Antonelli, Massimo|||0000-0003-3007-1670, Grieco, Domenico Luca|||0000-0002-4557-6308, Roca, Oriol|||0000-0003-3841-4551, Juffermans, Nicole P|||0000-0002-3039-6574, De Haro, Candelaria|||0000-0002-2668-1030, de Mendoza, Diego, Blanch, Lluís|||0000-0002-4158-7464, Camprubí-Rimblas, Marta|||0000-0002-4085-5324, Gomà, Gemma|||0000-0002-1890-4855, Artigas Raventós, Antoni|||0000-0002-8029-1017
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:252183
Acceso en línea:https://ddd.uab.cat/record/252183
https://dx.doi.org/urn:doi:10.1186/s13063-021-05991-2
Access Level:acceso abierto
Palabra clave:ICU
Acute respiratory failure
Hypoxemia
Prone position
Awake prone positioning
Invasive ventilation
Intubation
Randomized controlled trial
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spelling Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trialMorales-Quinteros, Luis|||0000-0002-8937-9824Schultz, Marcus J.|||0000-0003-3969-7792Serpa-Neto, AryAntonelli, Massimo|||0000-0003-3007-1670Grieco, Domenico Luca|||0000-0002-4557-6308Roca, Oriol|||0000-0003-3841-4551Juffermans, Nicole P|||0000-0002-3039-6574De Haro, Candelaria|||0000-0002-2668-1030de Mendoza, DiegoBlanch, Lluís|||0000-0002-4158-7464Camprubí-Rimblas, Marta|||0000-0002-4085-5324Gomà, Gemma|||0000-0002-1890-4855Artigas Raventós, Antoni|||0000-0002-8029-1017ICUAcute respiratory failureHypoxemiaProne positionAwake prone positioningInvasive ventilationIntubationInvasive ventilationRandomized controlled trialIt is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation-related complications. The PRONELIFE study is an investigator-initiated, international, multicenter, randomized clinical trial in patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Consecutive patients admitted to participating ICUs are randomly assigned to standard care with awake prone positioning, versus standard care without awake prone positioning. The primary endpoint is a composite of tracheal intubation and all-cause mortality in the first 14 days after enrolment. Secondary endpoints include time to tracheal intubation and effects of awake prone positioning on oxygenation parameters, dyspnea sensation, and complications. Other endpoints are the number of days free from ventilation and alive at 28 days, total duration of use of noninvasive respiratory support, total duration of invasive ventilation, length of stay in ICU and hospital, and mortality in ICU and hospital, and at 28, 60, and 90 days. We will also collect data regarding the tolerance of prone positioning. The PRONELIFE study is among the first randomized clinical trials investigating the effect of awake prone positioning on intubation rate in ICU patients with acute hypoxemic failure from any cause. The PRONELIFE study is sufficiently sized to determine the effect of awake prone positioning on intubation for invasive ventilation-patients are eligible in case of acute hypoxemic respiratory failure without restrictions regarding etiology. The PRONELIFE study is a pragmatic trial in which blinding is impossible-however, as around 35 ICUs worldwide will participate in this study, its findings will be highly generalizable. The findings of the PRONELIFE study have the potential to change clinical management of patients who may need invasive ventilation because of acute hypoxemic respiratory failure. ISRCTN ISRCTN11536318. Registered on 17 September 2021. The PRONELIFE study is registered at with reference number NCT04142736 (October, 2019).Universitat Autònoma de Barcelona. Departament de Medicina 22022-01-0120222022-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/252183https://dx.doi.org/urn:doi:10.1186/s13063-021-05991-2reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2521832026-06-06T12:50:31Z
dc.title.none.fl_str_mv Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
title Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
spellingShingle Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
Morales-Quinteros, Luis|||0000-0002-8937-9824
ICU
Acute respiratory failure
Hypoxemia
Prone position
Awake prone positioning
Invasive ventilation
Intubation
Invasive ventilation
Randomized controlled trial
title_short Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
title_full Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
title_fullStr Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
title_full_unstemmed Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
title_sort Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
dc.creator.none.fl_str_mv Morales-Quinteros, Luis|||0000-0002-8937-9824
Schultz, Marcus J.|||0000-0003-3969-7792
Serpa-Neto, Ary
Antonelli, Massimo|||0000-0003-3007-1670
Grieco, Domenico Luca|||0000-0002-4557-6308
Roca, Oriol|||0000-0003-3841-4551
Juffermans, Nicole P|||0000-0002-3039-6574
De Haro, Candelaria|||0000-0002-2668-1030
de Mendoza, Diego
Blanch, Lluís|||0000-0002-4158-7464
Camprubí-Rimblas, Marta|||0000-0002-4085-5324
Gomà, Gemma|||0000-0002-1890-4855
Artigas Raventós, Antoni|||0000-0002-8029-1017
author Morales-Quinteros, Luis|||0000-0002-8937-9824
author_facet Morales-Quinteros, Luis|||0000-0002-8937-9824
Schultz, Marcus J.|||0000-0003-3969-7792
Serpa-Neto, Ary
Antonelli, Massimo|||0000-0003-3007-1670
Grieco, Domenico Luca|||0000-0002-4557-6308
Roca, Oriol|||0000-0003-3841-4551
Juffermans, Nicole P|||0000-0002-3039-6574
De Haro, Candelaria|||0000-0002-2668-1030
de Mendoza, Diego
Blanch, Lluís|||0000-0002-4158-7464
Camprubí-Rimblas, Marta|||0000-0002-4085-5324
Gomà, Gemma|||0000-0002-1890-4855
Artigas Raventós, Antoni|||0000-0002-8029-1017
author_role author
author2 Schultz, Marcus J.|||0000-0003-3969-7792
Serpa-Neto, Ary
Antonelli, Massimo|||0000-0003-3007-1670
Grieco, Domenico Luca|||0000-0002-4557-6308
Roca, Oriol|||0000-0003-3841-4551
Juffermans, Nicole P|||0000-0002-3039-6574
De Haro, Candelaria|||0000-0002-2668-1030
de Mendoza, Diego
Blanch, Lluís|||0000-0002-4158-7464
Camprubí-Rimblas, Marta|||0000-0002-4085-5324
Gomà, Gemma|||0000-0002-1890-4855
Artigas Raventós, Antoni|||0000-0002-8029-1017
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona. Departament de Medicina
dc.subject.none.fl_str_mv ICU
Acute respiratory failure
Hypoxemia
Prone position
Awake prone positioning
Invasive ventilation
Intubation
Invasive ventilation
Randomized controlled trial
topic ICU
Acute respiratory failure
Hypoxemia
Prone position
Awake prone positioning
Invasive ventilation
Intubation
Invasive ventilation
Randomized controlled trial
description It is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation-related complications. The PRONELIFE study is an investigator-initiated, international, multicenter, randomized clinical trial in patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Consecutive patients admitted to participating ICUs are randomly assigned to standard care with awake prone positioning, versus standard care without awake prone positioning. The primary endpoint is a composite of tracheal intubation and all-cause mortality in the first 14 days after enrolment. Secondary endpoints include time to tracheal intubation and effects of awake prone positioning on oxygenation parameters, dyspnea sensation, and complications. Other endpoints are the number of days free from ventilation and alive at 28 days, total duration of use of noninvasive respiratory support, total duration of invasive ventilation, length of stay in ICU and hospital, and mortality in ICU and hospital, and at 28, 60, and 90 days. We will also collect data regarding the tolerance of prone positioning. The PRONELIFE study is among the first randomized clinical trials investigating the effect of awake prone positioning on intubation rate in ICU patients with acute hypoxemic failure from any cause. The PRONELIFE study is sufficiently sized to determine the effect of awake prone positioning on intubation for invasive ventilation-patients are eligible in case of acute hypoxemic respiratory failure without restrictions regarding etiology. The PRONELIFE study is a pragmatic trial in which blinding is impossible-however, as around 35 ICUs worldwide will participate in this study, its findings will be highly generalizable. The findings of the PRONELIFE study have the potential to change clinical management of patients who may need invasive ventilation because of acute hypoxemic respiratory failure. ISRCTN ISRCTN11536318. Registered on 17 September 2021. The PRONELIFE study is registered at with reference number NCT04142736 (October, 2019).
publishDate 2022
dc.date.none.fl_str_mv 2
2022-01-01
2022
2022-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/252183
https://dx.doi.org/urn:doi:10.1186/s13063-021-05991-2
url https://ddd.uab.cat/record/252183
https://dx.doi.org/urn:doi:10.1186/s13063-021-05991-2
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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