Clinical trial NCT03979222: Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study.
Official title: Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Failure
Keywords: ECMO
ARDS
Acute respiratory failure
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Royal Papworth Hospital Clinical Trials Unit
name: Aberdeen Royal Infirmary, NHS Grampian
name: Guy's and St Thomas' NHS Foundation Trust
name: Royal Brompton & Harefield Hospitals NHS Foundation Trust
name: Royal Papworth Hospital NHS Foundation Trust
name: University Hospitals of Leicester NHS Foundation Trust
name: Manchester University NHS Foundation Trust
name: NHS England
First posted: 2019-06-07
Enrollment: 1205
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Survival at ECMO ICU discharge
timeFrame: Up to 90 days.
Secondary outcomes:
measure: Duration of ECMO treatment.
timeFrame: Up to 90 days.
measure: Frequency of Complications
timeFrame: Up to 90 days.
Other outcomes:
Locations:
Study officials:
References:
citation: Warren A, Chiu YD, Villar SS, Fowles JA, Symes N, Barker J, Camporota L, Harvey C, Ledot S, Scott I, Vuylsteke A; NHS England-commissioned National ECMO Service. Outcomes of the NHS England National Extracorporeal Membrane Oxygenation Service for adults with respiratory failure: a multicentre observational cohort study. Br J Anaesth. 2020 Sep;125(3):259-266. doi: 10.1016/j.bja.2020.05.065. Epub 2020 Jul 28.