Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19

医学 氧气疗法 持续气道正压 插管 随机对照试验 呼吸衰竭 呼吸系统 2019年冠状病毒病(COVID-19) 机械通风 麻醉 内科学 疾病 传染病(医学专业) 阻塞性睡眠呼吸暂停
作者
Gavin D. Perkins,Chen Ji,Bronwen Connolly,Keith Couper,Ranjit Lall,J. Kenneth Baillie,Judy Bradley,Paul Dark,Chirag Dave,Anthony De Soyza,Anna Dennis,Anne Devrell,Sara Fairbairn,Hakim Ghani,Ellen Gorman,Christopher Green,Nicholas Hart,Siew Wan Hee,Zoe Kimbley,Shyam Madathil,Nicola McGowan,Benjamin Messer,Jay Naisbitt,Chloe Norman,Dhruv Parekh,Emma M Parkin,Jaimin Patel,Scott Regan,Clare Ross,Anthony Rostron,Mohammad Saim,Anita K. Simonds,Emma Skilton,Nigel Stallard,Michael Steiner,Rama Vancheeswaran,Joyce Yeung,Daniel F. McAuley,Nick Duffy,Martin Kelly,Dónal Concannon,Kathryn M. Ferguson,Declan McClintock,Rajeev Jha,Srinivas Murthy,Stephen O’Farrell,Cecilia M. O’Kane,Clare Ross,Richard Turner,Serge Miodragovic,Peter C.T. Hawkins,Jessie Welbourne,Colin Wells,Liana Lankester,Samuel D Waddy,Julian Lentaigne,Jay Nesbitt,Sarah Clarke,Catherine Houghton,Devaki O’Riordan,Kate Shepherd,Beth Turnpenny,Rosane Joseph,Michael Steiner,Clare Rossall,Rachel Mundin,Samuele Boschi,Hamish McAuley,Richard J. Russell,Sarah Diver,Omer Elneima,Wadah Ibrahim,Ahmed Yousuf,Sarah Edwards,Mohammad Saim,Bridget Hopkins,Lisa M. Kelly,Daniel Lenton,Helen Shackleford,Laura Thrasyvoulou,Heather Willis,Sara Fairbairn,Christopher Green,Jaimin Patel,Lucie Linhartová,Emma Hayton,Amy Chue,Ben Collins,Matt Page,Ed Birkhamshaw,Mary Bellamy,Hollie Bancroft,Emma Gallagher,Pearlene Antoine‐Pitterson,Beth Jones,Safia Begum,Sundip Dhani,Michael G. Crooks,Kayleigh Brindle,Shoaib Faruqi,Rachel Flockton,Emma Pinder,Susannah Thackray-Nocera,Keji Dalemo,James Doidge,Julia Edwards,J Douse,Stephanie Bell,Bally Purewal,Cathleen Chabo,Carol Buckman,Deborah Beeby,Georgina Gray,Rebecca Francis,Vanessa Rivers,Matthew Burton,Nicholas Innes,Sandy Ghattas,Rana Rabbani,Venkat Mahadevan,Venkateswaran Mahadevan,Alastair Green,Ben Burton,Christian Hacon,Elva Wilhelmsen,Paul R Hughes,Kai Lee,Richard Lowsby,Laurence H. Baker,P Matthews Ditorial Board,Varun Chauhan,Sheron Clarke,Duncan Fullerton,Claire Gabriel,Tom Houston,Diana Lees,Robert Normanton,Katherine Pagett,Sarah Thornley,H. T. Wright,Alison McMillan,Marta Babores,Xiang Lee,Thapas Nagarajan,Maureen Holland,Thomas Sanctuary,Richard Innes,Simon Fletcher,Nita Sehgal,Tracy Duncan,Justine Pooley,Emma Watkins,Harmesh Moudgil,Mandy Carnahan,Denise Donaldson,Deepak Rao,C Tey,Lynette Linkson,Tom Buttle,Jennifer Vidler,Nicola Griffiths,Alexander Hicks,Hitasha Rupani,Afaq Alfridi,Debi Barns,Elena Cowan,Mini David,Alex Darbyshire,Ben Giles,Claire Roberts,Claudia Lameirinhas,Daniel Neville,Ejaz Hossain,Fiona Thompson,Helena Edwards,Jen Naftel,Jonathan Winter,Kate Burrows,Laura Wiffen,Lauren Fox,Lisa Murray,Liz Hawes,Madhu Mamman,Maria Moon,Marie White,Megan Rowley,Nina Szarazova,Sally Gosling,Simon Cooper,Sonia Baryschpolec,Sophie Arndtz,Yasmin H-Davies,Yazeed Abed El Khaleq,Zoe Garner,Siyamini Vythilingam,Yingjja Yang,Dhruv Parekh,Shyam Madathil,Jaimin Patel,Colin Bergin,Michelle Bates,Christopher McGhee,Daniella Lynch,Khushpreet Bhandal,Kyriaki Tsakiridou,Amy Bamford,Lauren Cooper,Tony Whitehouse,Tonny Veenith,Elliott Forster,Steph Lane,Nick Adams,S.M. MacDonald,Sana Manan,Sebastian T. Lugg,Peer A Shah,Emily McKemey,Louise Crowley,G. Mussawar,Atena Gogokhia,Simon Gompertz,Catherine Snelson,Tessa Oelofse,Jeremy Wilson,Mansoor N. Bangash,Syed Huq,Farrukh Rauf,Davinder Dosanjh,Natasha Salmon,Joyce Tengende,Kay F Senior,Brendan Cooper,Benjamin Sutton,Ian Woolhouse,Anjali Crawshaw,Richard L. Thompson,Patricia Glynn,Jon Naylor,Joseph Alderman,Minesh Chotalia,Martin Le Breuilly,Nick P. Talbot,Greg Packer,C Carlin,Daniel Harvey,Alasdair Gray,Manish Gautam,Ingeborg Welters,David Hamilton,Hassan Burhan,Karl Hunter,Brian Johnston,María G. Vega López,Catherine Lowe,Suleman Mulla,Jaime Fernandez Roman,David Shaw,Alicia Waite,Victoria Waugh,Karen Williams,Anita K. Simonds,Kate Tatham,Ethel Black,Shaman Jhanji,Georges Ng Man Kwong,Ben Messer,Anthony De Soyza,Paul McAlinden,Sophie West,Vikram Anumakonda,Paul Dark,Liam McMorrow,Tracy Marsden,Nicola Proudfoot,Bethan Charles,Jessica Pendlebury,Bethan Blackledge,Alice Harvey,Karen Knowles,Reece Doonan,Stephanie J. Lee,Jane Perez,Melanie Slaughter,Melanie Taylor,Victoria Thomas,Emma Hardy,Nawar Diar Bakerly,Laura Catlow,Nasir Majeed,Daniel Horner,Liaquat Ali,Dorothy Hutchinson,Liz Fuller,James Dodd,Rahul Bhatnagar,Amelia Clive,Huzaifa Adamali,Anna Bibby,Daniel Higbee,H Welch,Emma Gendall,Louise Staddon,Anna Morley,Sam Clarke,Kerry Smith,Emily Perry,Naomi Rippon,Louise Jennings,Louise Solomon,Karen Alloway,Hannah Lee,Victoria Sandrey,Kirstie Bradburn,Alice Milne,Elizabeth Goff,Rachel Williams,Mohammed Ahmed,Susannah Bloch,Ahmed Zaki,Alistair Roy,Anthony Rostron,Lindsey Woods,Fiona Wakinshaw,Pamela Bainbridge,Peter Hersey,Mark G. Carpenter,Claire Leech,Laura O’Connor,Andrew Morrison,Elaine Rodgers,P. McAndrew,Gary Lear,Jim Coates,Maxwell Richardson,David M. Smith,William H. Green,Sarah M. Murray,Christopher Pennington,Huan De Wong,D. Land,Helen Wheeler,Matt A E Harvey,Mark Watson,Martin M. Brown,Ben Irving,Julie Bigg,Mae Felongco,Joe Mackenzie,Devesh Dhasmana,Rob Thompson,Patrick Lui,Fiona Adam,Fleur Davey,Julie Penman,Amanda McGregor,Patricia Cochrane,Korah Shalan,Will Bozic,Jaclyn Brown,John Carey,Claire Daffern,Emily Dight,Matthew Gane,Belinder Ghuman,Jo Grummett,Johnny Guck,Louisa Hamilton,Cat Hill,Maddy Hill,Chockalingam Muthiah,Emma Padfield,Jeskaran Rai,Kerry Raynes,Gregory Scott,Emily Stimpson,Natalie R. Strickland,Adrian Willis,Chen Ji,Ben Attwood,Inderjit Atwal,Penny Parsons,Rama Vancheeswaran,Shruthi Konda,Yadee Myint,Meera Mehta,Ambreen Iqbal Muhammad,Alessio Navarro,Adam Rochester,Saul Sundayi,Manish Patel,Andrew Smith,Colin J.R. Stewart,Matthew Tate,Erin McGarry,Claire Pearson,Berni Walsh,Lynn Glass,Karen Black,Suzanne Clements,Rosalind Boyle,Claire MacDonald,Leigh Hamilton,Gayle Moreland,Raymond Hamill,Harsha Reddy,Sara Smuts,Andrew Bentley
出处
期刊:JAMA [American Medical Association]
卷期号:327 (6): 546-546 被引量:282
标识
DOI:10.1001/jama.2022.0028
摘要

Importance

Continuous positive airway pressure (CPAP) and high-flow nasal oxygen (HFNO) have been recommended for acute hypoxemic respiratory failure in patients with COVID-19. Uncertainty exists regarding the effectiveness and safety of these noninvasive respiratory strategies.

Objective

To determine whether either CPAP or HFNO, compared with conventional oxygen therapy, improves clinical outcomes in hospitalized patients with COVID-19–related acute hypoxemic respiratory failure.

Design, Setting, and Participants

A parallel group, adaptive, randomized clinical trial of 1273 hospitalized adults with COVID-19–related acute hypoxemic respiratory failure. The trial was conducted between April 6, 2020, and May 3, 2021, across 48 acute care hospitals in the UK and Jersey. Final follow-up occurred on June 20, 2021.

Interventions

Adult patients were randomized to receive CPAP (n = 380), HFNO (n = 418), or conventional oxygen therapy (n = 475).

Main Outcomes and Measures

The primary outcome was a composite of tracheal intubation or mortality within 30 days.

Results

The trial was stopped prematurely due to declining COVID-19 case numbers in the UK and the end of the funded recruitment period. Of the 1273 randomized patients (mean age, 57.4 [95% CI, 56.7 to 58.1] years; 66% male; 65% White race), primary outcome data were available for 1260. Crossover between interventions occurred in 17.1% of participants (15.3% in the CPAP group, 11.5% in the HFNO group, and 23.6% in the conventional oxygen therapy group). The requirement for tracheal intubation or mortality within 30 days was significantly lower with CPAP (36.3%; 137 of 377 participants) vs conventional oxygen therapy (44.4%; 158 of 356 participants) (absolute difference, −8% [95% CI, −15% to −1%],P = .03), but was not significantly different with HFNO (44.3%; 184 of 415 participants) vs conventional oxygen therapy (45.1%; 166 of 368 participants) (absolute difference, −1% [95% CI, −8% to 6%],P = .83). Adverse events occurred in 34.2% (130/380) of participants in the CPAP group, 20.6% (86/418) in the HFNO group, and 13.9% (66/475) in the conventional oxygen therapy group.

Conclusions and Relevance

Among patients with acute hypoxemic respiratory failure due to COVID-19, an initial strategy of CPAP significantly reduced the risk of tracheal intubation or mortality compared with conventional oxygen therapy, but there was no significant difference between an initial strategy of HFNO compared with conventional oxygen therapy. The study may have been underpowered for the comparison of HFNO vs conventional oxygen therapy, and early study termination and crossover among the groups should be considered when interpreting the findings.

Trial Registration

isrctn.org Identifier:ISRCTN16912075
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