Is the Perfusion Index an Accurate Predictor of Return of Spontaneus Circulation in Out-of-hospital Cardiac Arrest

NCT ID: NCT05383885

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Death, Sudden, Cardiac; Perfusion Index; Return of Spontaneous Circulation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational cohort

The study is an observational study on a single cohort of consecutive out-of-hospital cardiac arrest patients.

All patients in the cohort will be monitored with a non-invasive pletismograph. No intervention will be administered to any patient and no decision on treatment will be based on the collected informations. Treating physicians will be blinded to collected values of perfusion index during the study

No interventions assigned to this group

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Saint Pierre

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Stefano Malinverni, MD, Ph.D

Role: CONTACT

stefano.malinverni@stpierre-bru.be

+32471268267

Diane De Longueville, MD

Role: CONTACT

diane.delongueville@stpierre-bru.be

Facility Contacts

Stefano Malinverni, MD, Ph.D

Role: primary

stefano.malinverni@stpierre-bru.be

0471268267

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CE/21-11-01

Identifier Type: -

Identifier Source: org_study_id