TY - JOUR
T1 - Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM)
T2 - a multicentre, open-label, randomised, phase 3 trial
AU - PRISM trial group
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 - Vohra, Ravinder
AU - Wilson, Matt
AU - Edwards, Mark
AU - Griffiths, Ewen
AU - Pritchard, Naomi
AU - Filippini, Claudia
AU - Aasmundstad, Tor
AU - Aksnes, Einar
AU - Alpers, Lise Merete
AU - Barratt-Due, Andreas
AU - Dahl, Anita
AU - Feldt, Linda
AU - Figari, Elisa
AU - Flåten, Eva
AU - Granheim, Karen
AU - Hagring, Minna
AU - Haugaa, Håkon
AU - Kjoesen, Gisle
AU - Klaevahaugen, Inge
AU - Lenz, Harald
AU - Myhre, Marianne
AU - Orrem, Hilde
AU - Stitt, Emily
AU - Toennessen, Tor Inge
AU - Al-Kadhimi, Samuel
AU - Anker, Robert
AU - Balint, Mihaela
AU - Barraclough, Lauren
AU - Black, Ethel
AU - Clayton, Matt
AU - Conneely, Leonora
AU - Edwards, Zara
AU - Eeles, Alex
AU - Evans, Matthew
AU - Gerstman, Michelle
AU - Greenshields, Nicole
AU - Harvey, Eleanor
AU - Hegarty, Aoife
AU - Hester, Natalie
AU - Hutchinson, Jenna
AU - Kasivisvanathan, Ramanathan
AU - Lawrence, Helen
AU - Marsh, Veronica
AU - Matthews, Laura
AU - Mazzola, Francesca
AU - McCanny, Jamie
AU - Morrison, Ben
AU - O'Mahony, Michelle
AU - Pang, Ching Ling
AU - Parkinson, David
AU - Pirie, Katrina
AU - Rao Baikady, Ravishankar
AU - Shovel, Louisa
AU - Smith, Lorna
AU - Tatham, Kate
AU - Thomas, Peter
AU - Uren, Sophie
AU - Walker, Susanna
AU - Wills, Alasdair
AU - Andreou, Prematie
AU - Howson, Alex
AU - Kaur, Jasmin
AU - Lewszuk, Adam
AU - Molina, Esther
AU - Ramsamy, Nirmalabaye
AU - Roberts, Emma
AU - Amaral, Vanessa
AU - Begum, Salma
AU - Bekele, Soliana
AU - Cashmore, Richard
AU - Correia, Carmen
AU - Dunkley, Steven
AU - Fernandez, Maria
AU - Fowler, Alexander
AU - Garcia, Amaia
AU - Della Giovampaola, Maria
AU - Greaves, Kathryn
AU - Griffiths, Bethan
AU - Haines, Ryan
AU - Haslop, Richard
AU - Hu, Ying
AU - Hui, Sarah
AU - Januszewska, Marta
AU - Manon, Vasi
AU - Martin, Tim
AU - May, Shaun
AU - Minicozzi, Annamaria
AU - Niebrzegowska, Edyta
AU - Oliveira, Monica
AU - Pates, Katherine
AU - Santos, Filipa
AU - Shahid, Tasnin
AU - Simili, Paolo
AU - Somerville, Alastair
AU - Subhedar, Emily
AU - Uddin, Ruzena
AU - Walker, Sophie
AU - Wan, Yize
AU - Whalley, Jan
AU - Zolfaghari, Parjam
AU - Gunter, Una
AU - Hodkinson, Gemma
AU - Howe, Gwenllian
AU - Baratozzi, Valentina
AU - Casotto, Giulia
AU - Darai, Giulia
AU - Ferrari, Erica
AU - Mistraletti, Giovanni
AU - Palmaverdi, Valentina
AU - Furlani, Stefano
AU - Priani, Paolo
AU - Ragazzi, Riccardo
AU - Salmaso, Marco
AU - Verri, Marco
AU - Volta, Carlo
AU - Nutt, Chris
AU - McKay, Emma
AU - O'Neill, Orla
AU - Patel, Jaimin
AU - Atterbury, Katie
AU - Ballinger, Sarah
AU - Carling, Natalie
AU - Ellis, Kaytie
AU - Gresty, Jo
AU - Melody, Teresa
AU - Monk, Jade
AU - Norman, Chloe
AU - Reeves, Eleanor
AU - Sampson, Julia
AU - Sutton, Peter
AU - Thomas, Marie
AU - Bamford, Amy
AU - Bergin, Colin
AU - Carrera, Ronald
AU - Cooper, Lauren
AU - Despy, Liesl
AU - Ellis, Karen
AU - Fellows, Emma
AU - Goundry, Stephanie
AU - Harkett, Samantha
AU - Ip, Peter
AU - Mason, Tracy
AU - McGhee, Christopher
AU - McLaughlin, Aisling
AU - Neal, Aoife
AU - Pope, Martin
AU - Porter, Stephanie
AU - Smith, Hazel
AU - Snelson, Catherine
AU - Spruce, Elaine
AU - Vigo, Ylenia
AU - Whitehouse, Arlo
AU - Whitehouse, Tony
AU - Donatiello, Maria
AU - Gazzanelli, Sergio
AU - Mezzapesa, Mario
AU - Savino, Martina
AU - Kanakaraj, Muthuraj
N1 - Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2021/11
Y1 - 2021/11
N2 - 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. Funding: National Institute for Health Research, Barts Charity, Intersurgical, Association of Anaesthetists, and Sapienza Università di Roma.
AB - 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. Funding: National Institute for Health Research, Barts Charity, Intersurgical, Association of Anaesthetists, and Sapienza Università di Roma.
UR - http://www.scopus.com/inward/record.url?scp=85118479631&partnerID=8YFLogxK
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 -