Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial

BACKGROUND: Sigh is a cyclic brief recruitment maneuver: previous physiologic studies showed that its use could be an interesting addition to pressure support ventilation to improve lung elastance, decrease regional heterogeneity, and increase release of surfactant. RESEARCH QUESTION: Is the clinica...

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Autores: Mauri, T, Foti, G, Fornari, C, Grasselli, G, Pinciroli, R, Lovisari, F, Tubiolo, D, Volta, CA, Spadaro, S, Rona, R, Rondelli, E, Navalesi, P, Garofalo, E, Knafelj, R, Gorjup, V, Colombo, R, Cortegiani, A, Zhou, JX, D'Andrea, R, Calamai, I, Gonzalez, AV, Roca, O, Grieco, DL, Jovaisa, T, Bampalis, D, Becher, T, Battaglini, D, Ge, HQ, Luz, M, Constantin, JM, Ranieri, M, Guerin, C, Mancebo, J, Pelosi, P, Fumagalli, R, Brochard, L, Pesenti, A
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2021
País:España
Recursos:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositório:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p4854
Acesso em linha:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4854
Access Level:Acceso aberto
Palavra-chave:ARDS
feasibility
pressure support
sigh
ventilation
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spelling Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical TrialMauri, TFoti, GFornari, CGrasselli, GPinciroli, RLovisari, FTubiolo, DVolta, CASpadaro, SRona, RRondelli, ENavalesi, PGarofalo, EKnafelj, RGorjup, VColombo, RCortegiani, AZhou, JXD'Andrea, RCalamai, IGonzalez, AVRoca, OGrieco, DLJovaisa, TBampalis, DBecher, TBattaglini, DGe, HQLuz, MConstantin, JMRanieri, MGuerin, CMancebo, JPelosi, PFumagalli, RBrochard, LPesenti, AARDSfeasibilitypressure supportsighventilationBACKGROUND: Sigh is a cyclic brief recruitment maneuver: previous physiologic studies showed that its use could be an interesting addition to pressure support ventilation to improve lung elastance, decrease regional heterogeneity, and increase release of surfactant. RESEARCH QUESTION: Is the clinical application of sigh during pressure support ventilation (PSV) feasible? STUDY DESIGN AND METHODS: We conducted a multicenter noninferiority randomized clinical trial on adult intubated patients with acute hypoxemic respiratory failure or ARDS undergoing PSV. Patients were randomized to the no-sigh group and treated by PSV alone, or to the sigh group, treated by PSV plus sigh (increase in airway pressure to 30 cm H2O for 3 s once per minute) until day 28 or death or successful spontaneous breathing trial. The primary end point of the study was feasibility, assessed as noninferiority (5% tolerance) in the proportion of patients failing assisted ventilation. Secondary outcomes included safety, physiologic parameters in the first week from randomization, 28-day mortality, and ventilator-free days. RESULTS: Two-hundred and fifty-eight patients (31% women; median age, 65 [54-75] years) were enrolled. In the sigh group, 23% of patients failed to remain on assisted ventilation vs 30% in the no-sigh group (absolute difference, -7%; 95% CI, -18% to 4%; P = .015 for noninferiority). Adverse events occurred in 12% vs 13% in the sigh vs no-sigh group (P = .852). Oxygenation was improved whereas tidal volume, respiratory rate, and corrected minute ventilation were lower over the first 7 days from randomization in the sigh vs no-sigh group. There was no significant difference in terms of mortality (16% vs 21%; P = .337) and ventilator-free days (22 [7-26] vs 22 [3-25] days; P = .300) for the sigh vs no-sigh group. INTERPRETATION: Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk.ELSEVIER2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4854CHESTISSN: 00123692ISSNe: 19313543reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p48542026-06-14T12:41:47Z
dc.title.none.fl_str_mv Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
title Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
spellingShingle Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
Mauri, T
ARDS
feasibility
pressure support
sigh
ventilation
title_short Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
title_full Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
title_fullStr Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
title_full_unstemmed Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
title_sort Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
dc.creator.none.fl_str_mv Mauri, T
Foti, G
Fornari, C
Grasselli, G
Pinciroli, R
Lovisari, F
Tubiolo, D
Volta, CA
Spadaro, S
Rona, R
Rondelli, E
Navalesi, P
Garofalo, E
Knafelj, R
Gorjup, V
Colombo, R
Cortegiani, A
Zhou, JX
D'Andrea, R
Calamai, I
Gonzalez, AV
Roca, O
Grieco, DL
Jovaisa, T
Bampalis, D
Becher, T
Battaglini, D
Ge, HQ
Luz, M
Constantin, JM
Ranieri, M
Guerin, C
Mancebo, J
Pelosi, P
Fumagalli, R
Brochard, L
Pesenti, A
author Mauri, T
author_facet Mauri, T
Foti, G
Fornari, C
Grasselli, G
Pinciroli, R
Lovisari, F
Tubiolo, D
Volta, CA
Spadaro, S
Rona, R
Rondelli, E
Navalesi, P
Garofalo, E
Knafelj, R
Gorjup, V
Colombo, R
Cortegiani, A
Zhou, JX
D'Andrea, R
Calamai, I
Gonzalez, AV
Roca, O
Grieco, DL
Jovaisa, T
Bampalis, D
Becher, T
Battaglini, D
Ge, HQ
Luz, M
Constantin, JM
Ranieri, M
Guerin, C
Mancebo, J
Pelosi, P
Fumagalli, R
Brochard, L
Pesenti, A
author_role author
author2 Foti, G
Fornari, C
Grasselli, G
Pinciroli, R
Lovisari, F
Tubiolo, D
Volta, CA
Spadaro, S
Rona, R
Rondelli, E
Navalesi, P
Garofalo, E
Knafelj, R
Gorjup, V
Colombo, R
Cortegiani, A
Zhou, JX
D'Andrea, R
Calamai, I
Gonzalez, AV
Roca, O
Grieco, DL
Jovaisa, T
Bampalis, D
Becher, T
Battaglini, D
Ge, HQ
Luz, M
Constantin, JM
Ranieri, M
Guerin, C
Mancebo, J
Pelosi, P
Fumagalli, R
Brochard, L
Pesenti, A
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv ARDS
feasibility
pressure support
sigh
ventilation
topic ARDS
feasibility
pressure support
sigh
ventilation
description BACKGROUND: Sigh is a cyclic brief recruitment maneuver: previous physiologic studies showed that its use could be an interesting addition to pressure support ventilation to improve lung elastance, decrease regional heterogeneity, and increase release of surfactant. RESEARCH QUESTION: Is the clinical application of sigh during pressure support ventilation (PSV) feasible? STUDY DESIGN AND METHODS: We conducted a multicenter noninferiority randomized clinical trial on adult intubated patients with acute hypoxemic respiratory failure or ARDS undergoing PSV. Patients were randomized to the no-sigh group and treated by PSV alone, or to the sigh group, treated by PSV plus sigh (increase in airway pressure to 30 cm H2O for 3 s once per minute) until day 28 or death or successful spontaneous breathing trial. The primary end point of the study was feasibility, assessed as noninferiority (5% tolerance) in the proportion of patients failing assisted ventilation. Secondary outcomes included safety, physiologic parameters in the first week from randomization, 28-day mortality, and ventilator-free days. RESULTS: Two-hundred and fifty-eight patients (31% women; median age, 65 [54-75] years) were enrolled. In the sigh group, 23% of patients failed to remain on assisted ventilation vs 30% in the no-sigh group (absolute difference, -7%; 95% CI, -18% to 4%; P = .015 for noninferiority). Adverse events occurred in 12% vs 13% in the sigh vs no-sigh group (P = .852). Oxygenation was improved whereas tidal volume, respiratory rate, and corrected minute ventilation were lower over the first 7 days from randomization in the sigh vs no-sigh group. There was no significant difference in terms of mortality (16% vs 21%; P = .337) and ventilator-free days (22 [7-26] vs 22 [3-25] days; P = .300) for the sigh vs no-sigh group. INTERPRETATION: Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4854
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4854
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ELSEVIER
publisher.none.fl_str_mv ELSEVIER
dc.source.none.fl_str_mv CHEST
ISSN: 00123692
ISSNe: 19313543
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
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instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
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