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

NCT03979222 | Completed FDA Device

• 1 other identifier: ECMO-001
• Study Type: observational
• Target: 1,205
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Failure

Keywords

ECMO; ARDS; Acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Duration of ECMO treatment.

  Up to 90 days.

• Frequency of Complications

  Up to 90 days.

Interventions

Extracorporeal Membrane Oxygenation DEVICE

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Cambridge: lead
• Royal Papworth Hospital Clinical Trials Unit: collaborator
• Aberdeen Royal Infirmary, NHS Grampian: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Royal Brompton & Harefield Hospitals NHS Foundation Trust: collaborator
• Royal Papworth Hospital NHS Foundation Trust: collaborator
• University Hospitals of Leicester NHS Foundation Trust: collaborator
• Manchester University NHS Foundation Trust: collaborator
• NHS England: collaborator

Related Publications (1)

• 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.

  PMID: 32736826 DERIVED

MeSH Terms

Interventions

Extracorporeal Membrane Oxygenation

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Foundation Doctor, Division of Anaesthesia

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 7, 2019
• Study Start: December 1, 2011
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08