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

Completed

• Conditions: Acute Respiratory Failure

• Registration Number: NCT03979222
• Lead Sponsor: University of Cambridge

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.

Study Timeline

• Study Start: 2011-12-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-15
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1205

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival at ECMO ICU discharge	Up to 90 days.	The proportion of patients who are alive at discharge from the ICU at the treating ECMO centre.

Secondary Outcome Measures

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