Skip to content

Cardinality Matching Study of Early v.s. Delayed VV ECMO in Severe Respiratory Failure

Cardinality Matching Study of Early v.s. Delayed VV ECMO in Severe Respiratory Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03981393
Enrollment
667
Registered
2019-06-10
Start date
2011-12-01
Completion date
2018-03-31
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, ECMO

Brief 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 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.

Interventions

None listed

Sponsors

University of Cambridge
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients included in the UK ECMO registry (see previous registration; NCT number awaited; protocol ECMO-001) * Patients with VV ECMO

Exclusion criteria

* Patients with inadequate or missing data for creation of propensity score models.

Design outcomes

Primary

MeasureTime frameDescription
Survival to ECMO ICU dischargeUp to 90 days.Percentage of patients alive at discharge from the ICU at the specialist ECMO centre

Secondary

MeasureTime frameDescription
Duration of ECMO treatmentUp to 90 days.Duration spent supported by active ECMO treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026