Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypoxemic Respiratory Failure

医学潮气量机械通风通风（建筑）随机对照试验体外麻醉随机化呼吸分钟容积呼吸系统外科内科学机械工程工程类

作者

James J. McNamee,Michael A. Gillies,Nicholas Barrett,Gavin D. Perkins,William Tunnicliffe,Duncan Young,Andrew Bentley,David A Harrison,Daniel Brodie,Andrew Boyle,Jonathan Millar,Tamás Szakmány,Jonathan Paul,Redmond Tully,Ashley Agus,Clíona McDowell,Colette E. Jackson,Daniel F. McAuley,Temi Adedoyin,Kayode Adeniji,Caroline Aherne,Gopal Anand Iyer,Prematie Andreou,Gill Arbane,Ian Angus,Gill Arbane,Pauline Austin,Karen Austin,Georg Auzinger,Jonathan Ball,Dorota Banach,Jonathan Paul,Leona Bannon,Lucy Barclay,Helena Barcraft-Barnes,Richard Beale,Sarah I. Bean,Andrew Bentley,Georgia Bercades,Colin Bergin,Sian Bhardwaj,Colin Bigham,Isobel Birkinshaw,Euan Black,Aneta Bociek,Andrew Bodenham,Malcolm Booth,Christine Bowyer,David Brealey,Stephen Brett,J.G. Brooks,Karen Burt,Louise Cabrelli,Leilani Cabreros,Hazel Cahill,A N Campbell,Luigi Camporota,Sara Campos,Julie Camsooksai,Ronald Carrera,Joseph Carter,Jaime Carungcong,Anelise Catelan-Zborowski,Susanne Cathcart,Shreekant Champanerkar,Matthew Charlton,Shiney Cherian,Linsey Christie,Srikanth Chukkambotla,Amy Clark,Sarah A. Clark,Richard A. Clark,I Clement,Eve Cocks,Stephen J. Cole,Sonia Cole,Jade Cole,Nick Coleman,Emma Connaughton,Andrew Conway Morris,Lauren Cooper,Ian A. Cooper,Carolyn Corbett,Sarah Cornell,Carmen Correia,V Cottam,Keith Couper,Laura Creighton,Maryam Crews,Neil Crooks,Jacqueline Curtin,Zoe Daly,Alan Davidson,Rhys Davies,Michelle Davies,Christopher Day,Mike Dean,Ged Dempsey,Anna Dennis,Susan Dermody,Liesl Despy,Murugesh Devaramani,Patricia Doble,Robert Docking,Adrian Donnelly,Natalie Dooley,Natalie Dormand,Andrew Drummond,Mark Dunn,Leigh Dunn,Christine Eastgate,Karen Ellis,Sarah Farnell,Helen Farrah,Emma Fellows,Tim Felton,Helder Filipe,Clare Finney,Simon J. Finney,Jillian Fitchett,Brian T. Gammon,Saibal Ganguly,Minerva Gellamucho,Susan Gibson,Charles L. Gibson,Lynn Gilfeather,Michael A. Gillies,Stuart Gillon,Shameer Gopal,Anthony Gordon,Stephanie Goundry,Lia Grainger,Neus Grau Novellas,Joanne Gresty,Mark Griffiths,Jamie Gross,Una Gunter,Karen Hallett,Samantha Harkett,Donna Harrison-Briggs,Louise Hartley,Ingrid Hass,Noel Hemmings,Steven Henderson,Helen Hill,Gemma Hodkinson,Kate Howard,Clare Howcroft,Ying Hu,Jonathan Hulme,Tariq Husain,Joanne Hutter,Dorothy Ilano,Richard Innes,Nicola Jacques,Sarah Aissi James,Sarah Jenkins,Paul Johnston,Brian Johnston,Colette Jones-Criddle,S. Kannan,Parminder Bhuie,Andrea Kelly,Sophie Kennedy-Hay,Liana Lankester,Anna Kluzik,Stéphane Ledot,Rosario Lim,Lucie Linhartová,Fei Long,Niall MacCallum,Sarah MacGill,Andrew Mackay,Sarah MacLean,Amber Markham,Daniel Martín,Tim Martin,Tracy Mason,Nick Mason,Justine McCann,Corrienne McCulloch,Christopher McGhee,Loren McGinley-Keag,Michael G. McLaughlin,Lia McNamee,Margaret McNeil,Laura Mee,Claire Mellis,Teresa Melody,Jeanette Mills,E. del Campo Molina,Matt Morgan,Mushiya Mpelembue,Stephanie Muldoon,Sheila Munt,Nazril Nordin,Christopher Nutt,Ruben Rodriguez,Aisling O’Neill,Valérie Page,Elankumaran Paramasivam,Dhruv Parekh,S. K. Patch,Sameer Patel,Lia Paton,Gavin D. Perkins,Manuel Pinto,David Pogson,Petra Polgarova,Jagtar Singh Pooni,Martin Pope,Grant Price,Jashmin Maria,Lynda Purdy,Alex Puxty,John Rae,Mark Raper,Henrik Reschreiter,Steve Rose,Anthony Rostron,Alistair Roy,Christine Ryan,Jung‐Hee Ryu,Kiran Salaunkey,Julia Sampson,Vivian Sathianathan,Lorraine Scaife,Simon WM Scott,Timothy Scott,Sumant Shanbhag,David M. Shaw,Malcolm Sim,Suveer Singh,Andrew Smallwood,Hazel Smith,John Smith,J. Lawton Smith,Deborah Smyth,Catherine Snelson,Michael Z. Spivey,Elaine Spruce,Charlotte Summers,Peter Sutton,Tamás Szakmány,Ling‐Pei Ho,Maie Templeton,Jessica Thrush,Redmond Tully,William Tunnicliffe,Ian Turner-Bone,Tonny Veenith,Alan Vuylsteke,Andrew Bentley,Jonathan Walker,Kate Ward,Timothy Walsh,Victoria Waugh,Colin Wells,Ingeborg Welters,Tony Whitehouse,Arlo Whitehouse,R. Chris Whitton,Elizabeth Wilby,Danielle Wilcox,Laura Wilding,James Williams,Karen Williams,Sarah Winnard,Lindsey Woods,Chris Wright,Neil Young,Xiaobei Zhao,Parjam Zolfaghari

出处

期刊：JAMA [American Medical Association]
日期：2021-09-21 卷期号：326 (11): 1013-1013 被引量：125

链接

jamanetwork.com nih.gov ac.uk ac.uk nih.govdoi.org

标识

DOI：10.1001/jama.2021.13374

摘要

Importance

In patients who require mechanical ventilation for acute hypoxemic respiratory failure, further reduction in tidal volumes, compared with conventional low tidal volume ventilation, may improve outcomes.

Objective

To determine whether lower tidal volume mechanical ventilation using extracorporeal carbon dioxide removal improves outcomes in patients with acute hypoxemic respiratory failure.

Design, Setting, and Participants

This multicenter, randomized, allocation-concealed, open-label, pragmatic clinical trial enrolled 412 adult patients receiving mechanical ventilation for acute hypoxemic respiratory failure, of a planned sample size of 1120, between May 2016 and December 2019 from 51 intensive care units in the UK. Follow-up ended on March 11, 2020.

Interventions

Participants were randomized to receive lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal for at least 48 hours (n = 202) or standard care with conventional low tidal volume ventilation (n = 210).

Main Outcomes and Measures

The primary outcome was all-cause mortality 90 days after randomization. Prespecified secondary outcomes included ventilator-free days at day 28 and adverse event rates.

Results

Among 412 patients who were randomized (mean age, 59 years; 143 [35%] women), 405 (98%) completed the trial. The trial was stopped early because of futility and feasibility following recommendations from the data monitoring and ethics committee. The 90-day mortality rate was 41.5% in the lower tidal volume ventilation with extracorporeal carbon dioxide removal group vs 39.5% in the standard care group (risk ratio, 1.05 [95% CI, 0.83-1.33]; difference, 2.0% [95% CI, −7.6% to 11.5%];P = .68). There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs 9.2 [95% CI, 7.9-10.4] days; mean difference, −2.1 [95% CI, −3.8 to −0.3];P = .02). Serious adverse events were reported for 62 patients (31%) in the extracorporeal carbon dioxide removal group and 18 (9%) in the standard care group, including intracranial hemorrhage in 9 patients (4.5%) vs 0 (0%) and bleeding at other sites in 6 (3.0%) vs 1 (0.5%) in the extracorporeal carbon dioxide removal group vs the control group. Overall, 21 patients experienced 22 serious adverse events related to the study device.

Conclusions and Relevance

Among patients with acute hypoxemic respiratory failure, the use of extracorporeal carbon dioxide removal to facilitate lower tidal volume mechanical ventilation, compared with conventional low tidal volume mechanical ventilation, did not significantly reduce 90-day mortality. However, due to early termination, the study may have been underpowered to detect a clinically important difference.

Trial Registration

ClinicalTrials.gov Identifier:NCT02654327

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