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

Acute Respiratory Failure Clinical Trial

— NHS ECMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979222
• Other study ID #: ECMO-001
• Status: Completed
• Start date: December 1, 2011
• Est. completion date: March 31, 2018

Study information

• Verified date: August 2019
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1205
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor

Collaborator

University of Cambridge

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at ECMO ICU discharge	The proportion of patients who are alive at discharge from the ICU at the treating ECMO centre.	Up to 90 days.
Secondary	Duration of ECMO treatment.	The time (hours) where the patient is actively supported by the ECMO circuit.	Up to 90 days.
Secondary	Frequency of Complications	The proportion of patients experiencing recognised complications of ECMO treatment.	Up to 90 days.