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

NCT05383885 | Unknown

• 1 other identifier: CE/21-11-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

cardiac arrest; perfusion index; Return of spontaneous circulation; End tidal CO2

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Re-arrest - Perfusion index

  From return of spontaneous circulation until hospital admission or re-arrest from any cause, whichever came first, assessed up to 2 hours after inclusion

Study Arms (1)

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

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with out-of-hospital or in-hospital cardiac arrest will be assessed for eligibility. After verifiying inclusion and exclusion criteria patients will be included in the study.

You may qualify if:

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

You may not qualify if:

• Pregnant patients
• Prisoners

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

Centre Hospitalier Saint Pierre

Brussels, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stefano Malinverni, MD, Ph.D

CONTACT

+32471268267; stefano.malinverni@stpierre-bru.be

Diane De Longueville, MD

CONTACT

diane.delongueville@stpierre-bru.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 20, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 21, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: One month after publication, indefinitely.
• Access Criteria: Any researcher with access to figshare

Locations

BE (1)