跳至主要内容
临床试验/NCT03981393
NCT03981393已完成不适用

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

University of Cambridge0 个研究点目标入组 667 人开始时间: 2011年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
667
主要终点
Survival to ECMO ICU discharge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Survival to ECMO ICU discharge

时间窗: Up to 90 days.

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

次要结局

  • Duration of ECMO treatment(Up to 90 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Warren

Academic Foundation Doctor

University of Cambridge

相似试验