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

August 15, 2019 updated by: Alex Warren, University of Cambridge

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who received ECMO as part of the NHS England-commissioned national respiratory ECMO service between 1st December 2011 and 31st December 2017.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival at ECMO ICU discharge
Time Frame: Up to 90 days.
The proportion of patients who are alive at discharge from the ICU at the treating ECMO centre.
Up to 90 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of ECMO treatment.
Time Frame: Up to 90 days.
The time (hours) where the patient is actively supported by the ECMO circuit.
Up to 90 days.
Frequency of Complications
Time Frame: Up to 90 days.
The proportion of patients experiencing recognised complications of ECMO treatment.
Up to 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cambridge

Collaborators

Guy's and St Thomas' NHS Foundation Trust
Manchester University NHS Foundation Trust
Royal Papworth Hospital Clinical Trials Unit
Bioscience Statistics Unit, Institute of Public Health, University of Cambridge
Aberdeen Royal Infirmary, NHS Grampian
Royal Brompton & Harefield Hospitals NHS Foundation Trust
Royal Papworth Hospital NHS Foundation Trust
University Hospitals of Leicester NHS Foundation Trust
NHS England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2011

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

March 31, 2018

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (ACTUAL)

June 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECMO-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Failure

Clinical Trials on Extracorporeal Membrane Oxygenation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe