Acute Respiratory FailureNHS ECMONCT03979222
Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study.
An observational study of Acute Respiratory Failure, run by University of Cambridge.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Extracorporeal Membrane Oxygenation
- Type of treatment
- Medical device
- How many people
- 1,205 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2011to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
About this 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.
Read the 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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Extracorporeal Membrane Oxygenation
- Keywords
- ECMO, ARDS, Acute respiratory failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Membrane OxygenationDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
Survival at ECMO ICU discharge
The proportion of patients who are alive at discharge from the ICU at the treating ECMO centre.
Measured: Up to 90 days.
Secondary outcomes (2)
Duration of ECMO treatment.
The time (hours) where the patient is actively supported by the ECMO circuit.
Measured: Up to 90 days.
Frequency of Complications
The proportion of patients experiencing recognised complications of ECMO treatment.
Measured: Up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Dec 2011
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Papworth Hospital Clinical Trials Unit, Aberdeen Royal Infirmary, NHS Grampian, Guy's and St Thomas' NHS Foundation Trust, Royal Brompton & Harefield Hospitals NHS Foundation Trust, Papworth Hospital NHS Foundation Trust, University Hospitals, Leicester, Manchester University NHS Foundation Trust, NHS England
- Responsible party
- Principal investigator, Alex Warren, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979222
- Sponsor's protocol ID
- ECMO-001
- Acronym
- NHS ECMO
- Status last verified
- Aug 2019
- First submitted
- 2 Jun 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32736826
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study.
- ClinicalTrials.gov ID
- NCT03979222
- Acronym / sponsor ID
- NHS ECMO / ECMO-001
- Conditions
- Acute Respiratory Failure
- Keywords
- ECMO, ARDS, Acute respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,205 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Royal Papworth Hospital Clinical Trials Unit, Aberdeen Royal Infirmary, NHS Grampian, Guy's and St Thomas' NHS Foundation Trust, Royal Brompton & Harefield Hospitals NHS Foundation Trust, Papworth Hospital NHS Foundation Trust, University Hospitals, Leicester, Manchester University NHS Foundation Trust, NHS England
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Membrane OxygenationECMO 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. | Device | – |
Primary outcome
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.
2 secondary outcomes
Duration of ECMO treatment.
Time frame: Up to 90 days.
Frequency of Complications
Time frame: Up to 90 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 32736826Warren 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by University of Cambridge.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at ECMO ICU discharge (time frame: Up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.