Clincosm LogoSign in Get a demo

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

Sponsor
University of Cambridge (Other)
Overall Status
Completed
CT.gov ID
NCT03981393
Collaborator
(none)
667
Enrollment
76
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    667 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Cardinality Matching Study of Early v.s. Delayed VV ECMO in Severe Respiratory Failure
    Actual Study Start Date :
    Dec 1, 2011
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    Mar 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    '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

    Outcome Measures

    Primary Outcome Measures

    1. Survival to ECMO ICU discharge [Up to 90 days.]

      Percentage of patients alive at discharge from the ICU at the specialist ECMO centre

    Secondary Outcome Measures

    1. Duration of ECMO treatment [Up to 90 days.]

      Duration spent supported by active ECMO treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Cambridge

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alex Warren, Academic Foundation Doctor, University of Cambridge
    ClinicalTrials.gov Identifier:
    NCT03981393
    Other Study ID Numbers:
    • ECMO-002
    First Posted:
    Jun 10, 2019
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Apr 27, 2021