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...
| Authors: | ; ; ; ; ; ; ; ; ; ; ; ; |
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| Format: | Article |
| Publication date: | 2022 |
| Country: | España |
| Institution: | Universitat Autònoma de Barcelona |
| Repository: | Dipòsit Digital de Documents de la UAB |
| Language: | English |
| OAI Identifier: | oai:ddd.uab.cat:252183 |
| Online Access: | https://ddd.uab.cat/record/252183 https://dx.doi.org/urn:doi:10.1186/s13063-021-05991-2 |
| Access Level: | Open access |
| Keyword: | ICU Acute respiratory failure Hypoxemia Prone position Awake prone positioning Invasive ventilation Intubation Randomized controlled trial |
| _version_ | 1878738959541993472 |
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| author | Morales-Quinteros, Luis|||0000-0002-8937-9824 |
| 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 |
| author_browse | Antonelli, Massimo|||0000-0003-3007-1670 Artigas Raventós, Antoni|||0000-0002-8029-1017 Blanch, Lluís|||0000-0002-4158-7464 Camprubí-Rimblas, Marta|||0000-0002-4085-5324 De Haro, Candelaria|||0000-0002-2668-1030 Gomà, Gemma|||0000-0002-1890-4855 Grieco, Domenico Luca|||0000-0002-4557-6308 Juffermans, Nicole P|||0000-0002-3039-6574 Morales-Quinteros, Luis|||0000-0002-8937-9824 Roca, Oriol|||0000-0003-3841-4551 Schultz, Marcus J.|||0000-0003-3969-7792 Serpa-Neto, Ary de Mendoza, Diego |
| 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 |
| collection | Dipòsit Digital de Documents de la UAB |
| 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). |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_b86c4b2ae2f9ff6959dce84becbfca0b |
| institution | Universitat Autònoma de Barcelona |
| instname_str | Universitat Autònoma de Barcelona |
| language | eng |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:ddd.uab.cat:252183 |
| publishDate | 2022 |
| publishDateSort | 2022 |
| reponame_str | Dipòsit Digital de Documents de la UAB |
| spelling | 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 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 ICU Acute respiratory failure Hypoxemia Prone position Awake prone positioning Invasive ventilation Intubation Randomized controlled 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 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). https://ddd.uab.cat/record/252183 https://dx.doi.org/urn:doi:10.1186/s13063-021-05991-2 |
| 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 Randomized controlled trial |
| title | 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_short | 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 |
| topic | ICU Acute respiratory failure Hypoxemia Prone position Awake prone positioning Invasive ventilation Intubation Randomized controlled trial |
| topic_facet | ICU Acute respiratory failure Hypoxemia Prone position Awake prone positioning Invasive ventilation Intubation Randomized controlled trial |
| url | https://ddd.uab.cat/record/252183 https://dx.doi.org/urn:doi:10.1186/s13063-021-05991-2 |