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临床试验/NCT05383885
NCT05383885Unknown不适用

A Prospective Observational Study of the Perfusion Index an a Predictor of Return of Spontaneus Circulation in Out of Hospital Cardiac Arrest

Centre Hospitalier Universitaire Saint Pierre1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
Return of Spontaneous Circulation - Perfusion index - absolute values

研究概览

简要总结

The purpose of this pilot feasibility study is to evaluate the ability of the Perfusion Index to predict the return to spontaneous circulation of the out-of-hospital cardiac arrest patient during cardiopulmonary resuscitation.

The performance of the perfusion index will also be compared to the current gold standard, end-tidal CO2 (EtCO2).

详细描述

The aim of this observational research is to measure the predictive performance the perfusion index to predict a return of a spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR).

The research focuses on patients in out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac arrest (IHCA) treated by the mobile intensive care unit of Saint Pierre University Hospital.

The study will be a pilot observational study during cardiac arrest. During the study period a non-invasive sensor will be connected to the patient's finger to measure continously and non-invasively the perfusion index. This non-invasive measurement is done by means of an infrared light which has no known risks for the health of the patient and which is usually used for the measurement of arterial oxygen saturation (SatO2). No intervention is planned as no decision will be taken on treatment based on the collected values of perfusion index during the arrest and post-arrest care of the participants.

The study will therefore be conducted during conventional advanced life support procedures without rescuers having access to the ongoing measurements.

The study will end when the participant returns to spontaneous circulation (RACS) or when patients is admitted to the emergency ward, whichever comes first in a time frame of maximum two hours.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
12 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Out of hospital cardiac arrest with an indication to initiate chest compressions
  • In hospital cardiac arrest with an indication to initiate chest compressions

排除标准

  • Pregnant patients
  • Prisoners

结局指标

主要结局

Return of Spontaneous Circulation - Perfusion index - absolute values

时间窗: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion

Receiver operating characteristic curve of the perfusion index to predict return of spontaneous circulation. Area under the curve of the receiver operating curve will be measured and reported for absolute values.

Return of Spontaneous Circulation - Perfusion index - trend values

时间窗: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion

Receiver operating characteristic curve of the perfusion index to predict return of spontaneous circulation. Area under the curve of the receiver operating curve will be measured and reported for trend values of the pulsatility index.

次要结局

  • Return of Spontaneous Circulation - EtCO2 - Perfusion index(From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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