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

Status Completed

Clinical 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 received ECMO with very severe hypoxaemia.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03981393
Study type	Observational
Source	University of Cambridge
Contact
Status	Completed
Phase
Start date	December 1, 2011
Completion date	March 31, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms