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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Respiratory Failure

Intervention / Treatment
-----------------
* Device: Extracorporeal Membrane Oxygenation


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECMO, ARDS, Acute respiratory failure