NCT02654327|UnknownPhase 3DMC
pRotective vEntilation With Veno-venouS Lung assisT in Respiratory Failure
REST
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · NIHR HTA
interventional
1,120
1 country
1
Study Start
May 12, 2016
Actual (reported)Primary Completion
March 12, 2020
Actual (reported)Study Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a trial of a new way of treating patients with respiratory failure. The investigators propose to deliver a multi-centre clinical trial to determine whether veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical ventilation improves outcomes and is cost-effective, in comparison with standard care in patients who are mechanically ventilated for acute hypoxaemic respiratory failure
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 10, 2016
Actual (reported)January 13, 2016
Actual (reported)May 12, 2016
Actual (reported)March 12, 2020
Actual (reported)April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
All cause mortality
90 days after randomisation
Tidal volume (ml/kg Predicted Body Weight)
day 2 and day 3 after randomisation
Ventilator free days
28 days after randomisation
Duration of ventilation in survivors
28 days after randomisation
Need for Extracorporeal Membrane Oxygenation (ECMO)
7 days after randomisation
Mortality rate
28 days, 6 months and 1 year after randomisation
Right Ventricular function
Baseline & Day 2/Day 3
Standard care with conventional lung protective mechanical ventilation
VV-ECCO2R to enable lower tidal volume mechanical ventilation (target tidal volume of ≤ 3ml/kg predicted body weight and a Pplat ≤ 25cmH20)
In the intervention arm a dual lumen catheter will be inserted into a central vein. VV-ECCO2R is commenced and managed as per study manual. Tidal volumes are then reduced on mechanical ventilation to enable lower tidal volume ventilation. Lower tidal volume facilitated by VV-ECCO2R will continue for a least 2 days up to a maximum of 7 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Belfast Health and Social Care Trust
Belfast, United Kingdom
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
Fitzgerald M, Millar J, Blackwood B, Davies A, Brett SJ, McAuley DF, McNamee JJ. Extracorporeal carbon dioxide removal for patients with acute respiratory failure secondary to the acute respiratory distress syndrome: a systematic review. Crit Care. 2014 May 15;18(3):222. doi: 10.1186/cc13875.
First Submitted
January 10, 2016
First Posted
January 13, 2016
Study Start
May 12, 2016
Actual (reported)Primary Completion
March 12, 2020
Actual (reported)PEEP in Patients With Acute Respiratory Failure
Contact the study team to confirm eligibility.
Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
Boyle AJ, Reddy K, Conlon J, Auzinger G, Bannard-Smith J, Barrett NA, Camporota L, Gillies MA, Jackson C, McDowell C, Patel B, Perkins GD, Szakmany T, Tunnicliffe W, Welters ID, McNamee JJ, McAuley DF, O'Kane CM. Evaluation of Plasma Biomarkers to Understand the Biology and Heterogeneity of Treatment Effect in Lower Tidal Volume Ventilation Facilitated by Extracorporeal CO2 Removal in Acute Hypoxemic Respiratory Failure: A Secondary Analysis of the REST Trial. Crit Care Explor. 2025 Mar 27;7(4):e1246. doi: 10.1097/CCE.0000000000001246. eCollection 2025 Apr 1.
Agus A, McNamee JJ, Jackson C, McAuley DF. Extracorporeal carbon dioxide removal compared to ventilation alone in patients with acute hypoxaemic respiratory failure: cost-utility analysis of the REST RCT. Health Technol Assess. 2023 Aug;29(33):1-34. doi: 10.3310/FCDQ8036.
Boyle AJ, McDowell C, Agus A, Logan D, Stewart JD, Jackson C, Mills J, McNamee JJ, McAuley DF. Acute hypoxaemic respiratory failure after treatment with lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal: long-term outcomes from the REST randomised trial. Thorax. 2023 Aug;78(8):767-774. doi: 10.1136/thorax-2022-218874. Epub 2022 Oct 5.
McNamee JJ, Gillies MA, Barrett NA, Perkins GD, Tunnicliffe W, Young D, Bentley A, Harrison DA, Brodie D, Boyle AJ, Millar JE, Szakmany T, Bannard-Smith J, Tully RP, Agus A, McDowell C, Jackson C, McAuley DF; REST Investigators. 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: The REST Randomized Clinical Trial. JAMA. 2021 Sep 21;326(11):1013-1023. doi: 10.1001/jama.2021.13374.
Stokes JW, Gannon WD, Rice TW. Extracorporeal Carbon Dioxide Removal or Extracorporeal Membrane Oxygenation: Why Should We Care? Crit Care Med. 2021 May 1;49(5):e546-e547. doi: 10.1097/CCM.0000000000004844. No abstract available.
Study Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 2, 2022
Record last verified: 2022-03
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