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临床试验/NCT04667936
NCT04667936已完成不适用

Evaluation of Impaired Sedation in Patients With Moderate to Severe COVID-19 ARDS

Goethe University1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
Agitation and sedation level

研究概览

简要总结

This study focuses on the evaluation of various factors repeatedly discussed in relation to the impaired sedation of intubated ventilated COVID-19 patients. The sedation response of >100 moderately to severely affected COVID-19 ARDS was evaluated. The sedation level was measured at the bedside using the Richmond Agitation and Sedation Scale and ventilator synchrony. The evaluation was performed according to the static evaluation plan with respect to age, storage therapy and organ failure.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • moderate to severe COVID-19 ARDS

排除标准

  • 未提供

结局指标

主要结局

Agitation and sedation level

时间窗: Change in average dosage within 8 hours.

Change of sedation level using the Richmond Agitation and Sedation Scale (RASS, range: -5\[Unarousable\] to +4 \[Combative\], normal condition=0 \[Alert and calm\])

Change in sedative dosage applied

时间窗: Change in average dosage within 8 hours.

Applied dosage of esketamine (measured in mg/kg/h)

Application of sedative

时间窗: 30 minutes after study enrolment

Applied dosage of esketamine (measured in mg/kg/h)

Application of opioid analgesic

时间窗: 30 minutes after study enrolment

Applied dosage of remifentanil (measured in µg/kg/min)

Patient Characteristics

时间窗: The data is recorded at the time of enrolment

Weight (in kilograms)

Position therapy

时间窗: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.

Number of positioning therapys during treatment

Change of application of opioid analgesic

时间窗: Change in average dosage within 8 hours.

Applied dosage of remifentanil (measured in µg/kg/min)

次要结局

  • Need for renal replacement therapy(Data collection is performed at the date of death from any cause or discharge up to 10 weeks.)
  • Need for extracorporeal membrane oxygenation (vvECMO)(Data collection is performed at the date of death from any cause or discharge up to 10 weeks.)

研究者

发起方
Goethe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabeth H. Adam

Senior Physician

Goethe University

研究点 (1)

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