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Completed

NCT Number: NCT03979222

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Survival at ECMO ICU discharge

    Time frame: Up to 90 days.

    The proportion of patients who are alive at discharge from the ICU at the treating ECMO centre.

Secondary outcomes

  1. Duration of ECMO treatment.

    Time frame: Up to 90 days.

    The time (hours) where the patient is actively supported by the ECMO circuit.

  2. Frequency of Complications

    Time frame: Up to 90 days.

    The proportion of patients experiencing recognised complications of ECMO treatment.

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • Aberdeen Royal Infirmary, NHS Grampian
  • Guy's and St Thomas' 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, Leicester

Registry information

Acronym: NHS ECMO

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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