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Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study.

Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03979222
Acronym
NHS ECMO
Enrollment
1205
Registered
2019-06-07
Start date
2011-12-01
Completion date
2018-03-31
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

ECMO, ARDS, Acute respiratory failure

Brief summary

This is an observational study of outcomes of the NHS England-commissioned national respiratory ECMO service, which has been active at six centres since December 2011. 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.

Detailed description

Recent randomised and observational studies suggest there may be a role for extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory failure that have not responded to conventional measures. 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.

Interventions

DEVICEExtracorporeal 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.

Sponsors

Royal Papworth Hospital Clinical Trials Unit
CollaboratorUNKNOWN
Aberdeen Royal Infirmary, NHS Grampian
CollaboratorUNKNOWN
Guy's and St Thomas' NHS Foundation Trust
CollaboratorOTHER
Royal Brompton & Harefield Hospitals NHS Foundation Trust
CollaboratorUNKNOWN
Royal Papworth Hospital NHS Foundation Trust
CollaboratorUNKNOWN
University Hospitals of Leicester NHS Foundation Trust
CollaboratorUNKNOWN
Manchester University NHS Foundation Trust
CollaboratorOTHER_GOV
NHS England
CollaboratorOTHER_GOV
University of Cambridge
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Ultimately at the discretion of the clinician at the relevant ECMO centre * Aged ≥16 years * Severe acute respiratory failure refractory to conventional management * No contra-indication to ongoing ECMO therapy

Exclusion criteria

* Any contra-indication to ongoing ECMO therapy * Need for ECMO due to other aetiology than acute respiratory failure (e.g. bridge to transplantation, extracorporeal CPR, isolated acute cardiac failure)

Design outcomes

Primary

MeasureTime frameDescription
Survival at ECMO ICU dischargeUp to 90 days.The proportion of patients who are alive at discharge from the ICU at the treating ECMO centre.

Secondary

MeasureTime frameDescription
Duration of ECMO treatment.Up to 90 days.The time (hours) where the patient is actively supported by the ECMO circuit.
Frequency of ComplicationsUp to 90 days.The proportion of patients experiencing recognised complications of ECMO treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026