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Clinical Trials/NCT05383885
NCT05383885
Unknown
Not Applicable

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 site in 1 country90 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Death, Sudden, Cardiac
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Enrollment
90
Locations
1
Primary Endpoint
Return of Spontaneous Circulation - Perfusion index - absolute values
Last Updated
3 years ago

Overview

Brief Summary

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).

Detailed Description

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. The decision to stop resuscitation procedures will be made in accordance with the European Resuscitation Council (ERC) recommendations and the Resuscitation Termination Rules (TOR) for cardiac arrest. Pulsatility index values will be sampled at a 0.5 Hertz frequency. These values will be tested for their ability to predict ROSC within 2 minutes. Similarly, EtCO2 values (as a gold standard) will be analyzed from the time of first measure. The sensitivity and specificity of the collected values of EtCO2 in the prediction of ROSC will be compared, at the end of the study to the diagnostic sensibility and specificity of different thresholds of the perfusion index. The patient's consent will be requested at the moment when he/she recovers consciousness allowing the comprehension and signature of a consent after the cardiac arrest.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire Saint Pierre
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Pregnant patients
  • Prisoners

Outcomes

Primary Outcomes

Return of Spontaneous Circulation - Perfusion index - absolute values

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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