Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study.
NCT ID: NCT03979222
Last Updated: 2019-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1205 participants
OBSERVATIONAL
2011-12-01
2018-03-31
Brief Summary
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The primary outcome of interest is the number of patients who survive to ICU discharge at the ECMO centre. The study also aims to identify factors predictive of outcome.
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Detailed Description
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In 2011, NHS England commissioned a national service to provide ECMO for severe respiratory failure at six centres across the country. Patients with severe respiratory failure are referred to the network if conventional measures are unsuccessful, and if accepted are transferred to an ECMO centre for specialist care. The criteria for admission is at the discretion of clinicians at each centre.
The NHS ECMO registry has been created by cross-referencing data submitted to the Extracorporeal Life Support Organisation (ELSO) in Ann Arbor, Michigan, with a tracker document identifying patients treated within the network. Analysis has been undertaken from December 2018 to March 2019.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Extracorporeal Membrane Oxygenation
ECMO provides extracorporeal gas exchange through use of a membrane oxygenator. Blood is drained from a central vein and returned after oxygenation into either the venous or arterial circulation dependent on configuration.
Eligibility Criteria
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Inclusion Criteria
* Aged ≥16 years
* Severe acute respiratory failure refractory to conventional management
* No contra-indication to ongoing ECMO therapy
Exclusion Criteria
* Need for ECMO due to other aetiology than acute respiratory failure (e.g. bridge to transplantation, extracorporeal CPR, isolated acute cardiac failure)
16 Years
ALL
No
Sponsors
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Royal Papworth Hospital Clinical Trials Unit
UNKNOWN
Aberdeen Royal Infirmary, NHS Grampian
UNKNOWN
Guy's and St Thomas' NHS Foundation Trust
OTHER
Royal Brompton & Harefield Hospitals NHS Foundation Trust
UNKNOWN
Royal Papworth Hospital NHS Foundation Trust
UNKNOWN
University Hospitals of Leicester NHS Foundation Trust
UNKNOWN
Manchester University NHS Foundation Trust
OTHER_GOV
NHS England
OTHER_GOV
University of Cambridge
OTHER
Responsible Party
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Alex Warren
Academic Foundation Doctor, Division of Anaesthesia
References
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Warren A, Chiu YD, Villar SS, Fowles JA, Symes N, Barker J, Camporota L, Harvey C, Ledot S, Scott I, Vuylsteke A; NHS England-commissioned National ECMO Service. Outcomes of the NHS England National Extracorporeal Membrane Oxygenation Service for adults with respiratory failure: a multicentre observational cohort study. Br J Anaesth. 2020 Sep;125(3):259-266. doi: 10.1016/j.bja.2020.05.065. Epub 2020 Jul 28.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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ECMO-001
Identifier Type: -
Identifier Source: org_study_id
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