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

Death, Sudden, Cardiac Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383885
• Other study ID #: CE/21-11-01
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: Stefano Malinverni, MD, Ph.D
• Phone: +32471268267
• Email: stefano.malinverni[@]stpierre-bru.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden
• Death, Sudden, Cardiac
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Perfusion Index
• Return of Spontaneous Circulation

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Saint Pierre	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Re-arrest - Perfusion index	Receiver operating characteristic curve of the perfusion index to predict re-arrest. Area under the curve of the receiver operating curve will be measured and reported for absolute values.	From return of spontaneous circulation until hospital admission or re-arrest from any cause, whichever came first, assessed up to 2 hours after inclusion
Primary	Return of Spontaneous Circulation - Perfusion index - absolute values	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.	From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion
Primary	Return of Spontaneous Circulation - Perfusion index - trend values	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.	From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion
Secondary	Return of Spontaneous Circulation - EtCO2 - Perfusion index	A receiver operating characteristic curve of the perfusion index to predict return of spontaneous circulation will be plotted against a receiver operating characteristic curve of end-tidal CO2 to predict return of spontaneous circulation. Area under the curve of the two receiver operating curve will be compared and assessed for superiority.	From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion