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临床试验/NCT05780255
NCT05780255已完成不适用

Quality of Life 1y and 2 y After VV-ECMO for COVID-19, Measured by the 36-item Short Form Health Survey

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年4月20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
28
试验地点
1
主要终点
Quality of life 1y after ECMO insertion

研究概览

简要总结

This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients.

详细描述

The investigators follow our COVID-19 patients supported by ECMO, we make phone calls or real-life visits to pthe patients to score the quality of life, by using the SF-36. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality , social functioning , role emotional , and mental health.

The participants are contacted 3 months, 6months, 1year and 2 years after the ECMO support started for evaluation of the SF-36.

研究设计

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

入排标准

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

入选标准

  • Patients with PCR-confirmed COVID-19 infection AND
  • Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.

排除标准

  • 未提供

结局指标

主要结局

Quality of life 1y after ECMO insertion

时间窗: 1 year

Result of SF-36 1 year after VV-ECMO insertion

Quality of life 2y after ECMO insertion

时间窗: 2 years

Result of SF-36 2 years after VV-ECMO insertion

in-hospital mortality

时间窗: mortality during hospitalisation, up to two years

次要结局

  • Duration of mechanical ventilation(2 years)
  • death after hospital discharge(after discharge from the hospital upon 2 years after)
  • LOS ICU(from the day of intensive care unit admission until the day of transfer to the ward, up to two years)
  • Lung complications requiring surgical treatment(From the start of VV-ECMO support until weaning of VV-ECMO, up to two years)
  • LOS hospital(from the day of hospital admission until the day that the participant is transferred to home, up to two years)
  • Incidence of acute kidney injury(from the day of hospital admission until the day that the participant is transferred to home, up to two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Quality of Life 1y and 2 y After VV-ECMO for COVID-19 | 临床试验