Acute Respiratory FailureNCT03981393
Cardinality Matching Study of Early v.s. Delayed VV ECMO in Severe Respiratory Failure
An observational study of Acute Respiratory Failure and ECMO, run by University of Cambridge.
Trial summary
Clinical reasoning and recent data suggest that early use of venovenous extracorporeal membrane oxygenation in refractory respiratory failure may confer a survival advantage. This retrospective matched study will assess whether patients who received VV ECMO at less severe hypoxaemia had differing outcomes to those who… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Respiratory Failure, ECMO
- How many people
- 667 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: This is a prespecified secondary analysis of the UK ECMO registry. Inclusion criteria are ultimately at the discretion of each recruiting centre, but includes adult patients with potentially reversible acute respiratory failure without absolute contraindications to ECMO therapy.
Who may be able to join
- Patients included in the UK ECMO registry (see previous registration; NCT number awaited; protocol ECMO-001)
- Patients with VV ECMO
Who cannot join
- Patients with inadequate or missing data for creation of propensity score models.
About this study
Clinical reasoning and recent data suggest that early use of venovenous extracorporeal membrane oxygenation in refractory respiratory failure may confer a survival advantage.
This retrospective matched study will assess whether patients who received VV ECMO at less severe hypoxaemia had differing outcomes to those who received ECMO with very severe hypoxaemia.
Read the detailed description
VV ECMO is increasingly used in refractory respiratory failure. Despite advances in lung protective ventilation strategies, patients who have severe respiratory failure often develop complications from mechanical ventilation, including volutrauma and barotrauma. ECMO allows gas exchange to occur extracorporeally and may reduce the potential burden of iatrogenic lung injury by allowing a reduction of volume and pressure support - a 'lung rest' strategy. It is theorised that earlier intitiation of ECMO may allow for better outcomes, as there will have been less time for iatrogenic lung injury to occur.
The UK ECMO registry has been collected of patients treated under the NHS England commissioned respiratory ECMO service since 2011. This study has been previously registered and publication is intended shortly.
Patients will be extracted from this registry if they received VV ECMO. Propensity matching scores will be created and patients will be stratified into groups of 'early' vs 'delayed' ECMO, based on their probability of being in either group.
Patients will be divided into cohorts based on the median PaO2/FiO2 ratio at decision to cannulate ('less severe hypoxaemia') and ('very severe hypoxaemia'). Matched cohorts will be created correcting for key confounding factors (age, primary diagnosis, duration of pre-ECMO ventilation and PaCO2), using cardinality matching (a novel technique described by Zubizaretta et al. in 2014) and traditional propensity-score-based methods.
The technique with greater balance and statistical power (as defined by sample size) will be selected for the primary analysis.
Further analyses will assess the relationship between hypoxaemia at decision-to-cannulate and confounding factors as above.
- Conditions
- Acute Respiratory Failure, ECMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 'Less severe hypoxaemia' | PaO2/FiO2 ratio > 68 mmHg (9.1kPa) at decision-to-cannulate | |
| 'Very severe hypoxaemia' | PaO2/FiO2 ratio ≤ 68 mmHg (9.1kPa) at decision-to-cannulate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to ECMO ICU discharge
Percentage of patients alive at discharge from the ICU at the specialist ECMO centre
Measured: Up to 90 days.
Secondary outcomes (1)
Duration of ECMO treatment
Duration spent supported by active 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 posted10 Jun 2019
- Study start1 Dec 2011
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Warren, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981393
- Sponsor's protocol ID
- ECMO-002
- Status last verified
- Apr 2021
- First submitted
- 6 Jun 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Access to IPD is via the UK ECMO network steering group. Enquiries in the first instance can be made to Dr Alain Vuylsteke, at a.vuylsteke@nhs.net
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardinality Matching Study of Early v.s. Delayed VV ECMO in Severe Respiratory Failure
- ClinicalTrials.gov ID
- NCT03981393
- Acronym / sponsor ID
- ECMO-002
- Conditions
- Acute Respiratory Failure, ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 10 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.
Clinical reasoning and recent data suggest that early use of venovenous extracorporeal membrane oxygenation in refractory respiratory failure may confer a survival advantage.
This retrospective matched study will assess whether patients who received VV ECMO at less severe hypoxaemia had differing outcomes to those who received ECMO with very severe hypoxaemia.
Detailed description
VV ECMO is increasingly used in refractory respiratory failure. Despite advances in lung protective ventilation strategies, patients who have severe respiratory failure often develop complications from mechanical ventilation, including volutrauma and barotrauma. ECMO allows gas exchange to occur extracorporeally and may reduce the potential burden of iatrogenic lung injury by allowing a reduction of volume and pressure support - a 'lung rest' strategy. It is theorised that earlier intitiation of ECMO may allow for better outcomes, as there will have been less time for iatrogenic lung injury to occur.
The UK ECMO registry has been collected of patients treated under the NHS England commissioned respiratory ECMO service since 2011. This study has been previously registered and publication is intended shortly.
Patients will be extracted from this registry if they received VV ECMO. Propensity matching scores will be created and patients will be stratified into groups of 'early' vs 'delayed' ECMO, based on their probability of being in either group.
Patients will be divided into cohorts based on the median PaO2/FiO2 ratio at decision to cannulate ('less severe hypoxaemia') and ('very severe hypoxaemia'). Matched cohorts will be created correcting for key confounding factors (age, primary diagnosis, duration of pre-ECMO ventilation and PaCO2), using cardinality matching (a novel technique described by Zubizaretta et al. in 2014) and traditional propensity-score-based methods.
The technique with greater balance and statistical power (as defined by sample size) will be selected for the primary analysis.
Further analyses will assess the relationship between hypoxaemia at decision-to-cannulate and confounding factors as above.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Less severe hypoxaemia' | – | –PaO2/FiO2 ratio > 68 mmHg (9.1kPa) at decision-to-cannulate |
| 'Very severe hypoxaemia' | – | –PaO2/FiO2 ratio ≤ 68 mmHg (9.1kPa) at decision-to-cannulate |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a prespecified secondary analysis of the UK ECMO registry. Inclusion criteria are ultimately at the discretion of each recruiting centre, but includes adult patients with potentially reversible acute respiratory failure without absolute contraindications to ECMO therapy.
Key inclusion criteria (2 listed)
- Patients included in the UK ECMO registry (see previous registration; NCT number awaited; protocol ECMO-001)
- Patients with VV ECMO
Key exclusion criteria (1 listed)
- Patients with inadequate or missing data for creation of propensity score models.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival to ECMO ICU discharge
Time frame: Up to 90 days.
Percentage of patients alive at discharge from the ICU at the specialist ECMO centre
1 secondary outcome
Duration of ECMO treatment
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 27 Apr 2021.
- Individual participant dataSharing planned: Undecided. Access to IPD is via the UK ECMO network steering group. Enquiries in the first instance can be made to Dr Alain Vuylsteke, at a.vuylsteke@nhs.net
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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 and ECMO, 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 2 inclusion and 1 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 27 Apr 2021. 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 to 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?
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 27 Apr 2021.