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临床试验/NCT04487769
NCT04487769已完成不适用

Early Lung Ultrasound Score Predicts Duration of Ventilation and ICU Mortality in COVID-19 Invasively Ventilated Patients

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2020年6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
137
试验地点
1
主要终点
Liberation from invasive ventilation

研究概览

简要总结

To assess the prognostic performance of an early global LUS score with respect to the mortality in ICU and duration of ventilation.

详细描述

This is an international multicenter cohort study on data collected between March and April 2020. The first available lung ultrasound examination that used a 12-regions approach was used to calculate the global LUS score.

Patients are included if they fulfilled the following criteria: 1) admitted to one of the participating ICU; 2) for invasive ventilation; 3) for respiratory failure due to confirmed COVID-19; and 4) having had a LUS examination performed within the first week of start of invasive ventilation.

The primary and secondary outcomes were liberation from invasive ventilation and mortality.

Demographic, clinical and outcome variables will be presented as percentages for categorical variables and as medians with interquartile ranges (IQR) for continuous variables.

Receiver operating characteristics (ROC) analysis will be used to derive the prognostic discriminatory performance of global LUS score in determining succesful extubation and mortality at day 28. The Youden index will be used to derive the optimal cut-off. The association of global LUS with unfavourable outcomes are analyzed with Cox proportional hazard analysis (for successful extubation and alive at day 28), logistic regression models (mortality at day 28). Hazard ratio or odds ratio with 95% confidence intervals were calculated for each outcome.

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

入选标准

  • Admitted to an ICU participating in this study between February 1, 2020 and April 30, 2020
  • Confirmed with reverse transcriptase polymerase chain reaction (RT-PCR) COVID-19 infection
  • Having had received invasive ventilation
  • Having had examined at least once with lung ultrasound under invasive ventilation

排除标准

  • Age <18 years
  • First examination with LUS in patients already under extracorporeal membrane oxygenation (ECMO) support.

结局指标

主要结局

Liberation from invasive ventilation

时间窗: 28 days

Patient who survived but remained invasively ventilated up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.

次要结局

  • Mortality(28 days)

研究者

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

Prof. Dr. Marcus J. Schultz

Prof. M.J. Schultz, MD, PhD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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