Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial

Rupert Pearse; Marco Ranieri; Tom Abbott; Mari Liis Pakats; Edoardo Piervincenzi; Akshaykumar Patel; Brennan Kahan; Andrew Rhodes; Priyanthi Dias; Russell Hewson; Ib Jammer; Michelle Chew; Cesar Aldecoa; Reitze Rodseth; Bruce Biccard; Tim Stephens; Sara Payne; David Hepworth; Soeren Pischke; Joerund Asvall; John Hausken; Shaman Jhanji; Martin Rooms; Neil Flint; Dawn Hales; Tamas Szakmany; Andrew Leitch; Savino Spadaro; Davide Chiumello; Paul Johnston; Joyce Yeung; Guglielmo Tellan; Tonny Veenith; Josep Macmillan; Pierpaolo Terragni; Caroline Sander; Vidya Kasipandian; Tahania Ahmad; Aaron Lee; Marcello Tammaro; Danny McAuley; Simon Skene; Emma McKay; Orla O'Neill; Aisling McLaughlin; Anthony Murphy; Stephen Wright; Katherine Cullen; Laura Graham; Matthew Jackson; PRISM trial group

doi:10.1016/S2213-2600(21)00089-8

Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial

Rupert Pearse^*, Marco Ranieri, Tom Abbott, Mari Liis Pakats, Edoardo Piervincenzi, Akshaykumar Patel, Brennan Kahan, Andrew Rhodes, Priyanthi Dias, Russell Hewson, Ib Jammer, Michelle Chew, Cesar Aldecoa, Reitze Rodseth, Bruce Biccard, Tim Stephens, Sara Payne, David Hepworth, Soeren Pischke, Joerund AsvallJohn Hausken, Shaman Jhanji, Martin Rooms, Neil Flint, Dawn Hales, Tamas Szakmany, Andrew Leitch, Savino Spadaro, Davide Chiumello, Paul Johnston, Joyce Yeung, Guglielmo Tellan, Tonny Veenith, Josep Macmillan, Pierpaolo Terragni, Caroline Sander, Vidya Kasipandian, Tahania Ahmad, Aaron Lee, Marcello Tammaro, Danny McAuley, Simon Skene, Emma McKay, Orla O'Neill, Aisling McLaughlin, Anthony Murphy, Stephen Wright, Katherine Cullen, Laura Graham, Matthew Jackson, PRISM trial group

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

40 Citations (Scopus)

Abstract

Background
Respiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity.

Methods
PRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545.

Findings
Between Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1·01 [95% CI 0·81–1·24]; p=0·95). 200 (8·9%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability.

Interpretation
In this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended.

Original language	English
Pages (from-to)	1221-1230
Number of pages	10
Journal	The Lancet Respiratory Medicine
Volume	9
Issue number	11
Early online date	18 Jun 2021
DOIs	https://doi.org/10.1016/S2213-2600(21)00089-8
Publication status	Published - Nov 2021

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

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Cite this

Pearse, R., Ranieri, M., Abbott, T., Pakats, M. L., Piervincenzi, E., Patel, A., Kahan, B., Rhodes, A., Dias, P., Hewson, R., Jammer, I., Chew, M., Aldecoa, C., Rodseth, R., Biccard, B., Stephens, T., Payne, S., Hepworth, D., Pischke, S., ... PRISM trial group (2021). Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial. The Lancet Respiratory Medicine, 9(11), 1221-1230. https://doi.org/10.1016/S2213-2600(21)00089-8

@article{303dbaa10adb4a14b404195dd1eb075e,

title = "Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial",

abstract = "BackgroundRespiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity.MethodsPRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545.FindingsBetween Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1·01 [95% CI 0·81–1·24]; p=0·95). 200 (8·9%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability.InterpretationIn this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended.",

author = "Rupert Pearse and Marco Ranieri and Tom Abbott and Pakats, {Mari Liis} and Edoardo Piervincenzi and Akshaykumar Patel and Brennan Kahan and Andrew Rhodes and Priyanthi Dias and Russell Hewson and Ib Jammer and Michelle Chew and Cesar Aldecoa and Reitze Rodseth and Bruce Biccard and Tim Stephens and Sara Payne and David Hepworth and Soeren Pischke and Joerund Asvall and John Hausken and Shaman Jhanji and Martin Rooms and Neil Flint and Dawn Hales and Tamas Szakmany and Andrew Leitch and Savino Spadaro and Davide Chiumello and Paul Johnston and Joyce Yeung and Guglielmo Tellan and Tonny Veenith and Josep Macmillan and Pierpaolo Terragni and Caroline Sander and Vidya Kasipandian and Tahania Ahmad and Aaron Lee and Marcello Tammaro and Danny McAuley and Simon Skene and Emma McKay and Orla O'Neill and Aisling McLaughlin and Anthony Murphy and Stephen Wright and Katherine Cullen and Laura Graham and Matthew Jackson and {PRISM trial group}",

year = "2021",

month = nov,

doi = "10.1016/S2213-2600(21)00089-8",

language = "English",

volume = "9",

pages = "1221--1230",

journal = "The Lancet Respiratory Medicine",

issn = "2213-2600",

publisher = "Elsevier Ltd",

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Pearse, R, Ranieri, M, Abbott, T, Pakats, ML, Piervincenzi, E, Patel, A, Kahan, B, Rhodes, A, Dias, P, Hewson, R, Jammer, I, Chew, M, Aldecoa, C, Rodseth, R, Biccard, B, Stephens, T, Payne, S, Hepworth, D, Pischke, S, Asvall, J, Hausken, J, Jhanji, S, Rooms, M, Flint, N, Hales, D, Szakmany, T, Leitch, A, Spadaro, S, Chiumello, D, Johnston, P, Yeung, J, Tellan, G, Veenith, T, Macmillan, J, Terragni, P, Sander, C, Kasipandian, V, Ahmad, T, Lee, A, Tammaro, M, McAuley, D, Skene, S, McKay, E, O'Neill, O, McLaughlin, A, Murphy, A, Wright, S, Cullen, K , Graham, L, Jackson, M & PRISM trial group 2021, 'Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial', The Lancet Respiratory Medicine, vol. 9, no. 11, pp. 1221-1230. https://doi.org/10.1016/S2213-2600(21)00089-8

Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial. / Pearse, Rupert; Ranieri, Marco; Abbott, Tom et al.
In: The Lancet Respiratory Medicine, Vol. 9, No. 11, 11.2021, p. 1221-1230.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial

AU - Pearse, Rupert

AU - Ranieri, Marco

AU - Abbott, Tom

AU - Pakats, Mari Liis

AU - Piervincenzi, Edoardo

AU - Patel, Akshaykumar

AU - Kahan, Brennan

AU - Rhodes, Andrew

AU - Dias, Priyanthi

AU - Hewson, Russell

AU - Jammer, Ib

AU - Chew, Michelle

AU - Aldecoa, Cesar

AU - Rodseth, Reitze

AU - Biccard, Bruce

AU - Stephens, Tim

AU - Payne, Sara

AU - Hepworth, David

AU - Pischke, Soeren

AU - Asvall, Joerund

AU - Hausken, John

AU - Jhanji, Shaman

AU - Rooms, Martin

AU - Flint, Neil

AU - Hales, Dawn

AU - Szakmany, Tamas

AU - Leitch, Andrew

AU - Spadaro, Savino

AU - Chiumello, Davide

AU - Johnston, Paul

AU - Yeung, Joyce

AU - Tellan, Guglielmo

AU - Veenith, Tonny

AU - Macmillan, Josep

AU - Terragni, Pierpaolo

AU - Sander, Caroline

AU - Kasipandian, Vidya

AU - Ahmad, Tahania

AU - Lee, Aaron

AU - Tammaro, Marcello

AU - McAuley, Danny

AU - Skene, Simon

AU - McKay, Emma

AU - O'Neill, Orla

AU - McLaughlin, Aisling

AU - Murphy, Anthony

AU - Wright, Stephen

AU - Cullen, Katherine

AU - Graham, Laura

AU - Jackson, Matthew

AU - PRISM trial group

PY - 2021/11

Y1 - 2021/11

N2 - BackgroundRespiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity.MethodsPRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545.FindingsBetween Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1·01 [95% CI 0·81–1·24]; p=0·95). 200 (8·9%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability.InterpretationIn this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended.

AB - BackgroundRespiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity.MethodsPRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545.FindingsBetween Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1·01 [95% CI 0·81–1·24]; p=0·95). 200 (8·9%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability.InterpretationIn this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended.

U2 - 10.1016/S2213-2600(21)00089-8

DO - 10.1016/S2213-2600(21)00089-8

M3 - Article

C2 - 34153272

AN - SCOPUS:85118479631

SN - 2213-2600

VL - 9

SP - 1221

EP - 1230

JO - The Lancet Respiratory Medicine

JF - The Lancet Respiratory Medicine

IS - 11

ER -

Pearse R, Ranieri M, Abbott T, Pakats ML, Piervincenzi E, Patel A et al. Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial. The Lancet Respiratory Medicine. 2021 Nov;9(11):1221-1230. Epub 2021 Jun 18. doi: 10.1016/S2213-2600(21)00089-8

Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial

Abstract

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