Resuscitation and Capillary Reperfusion (ReCapp)

REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion

Persistent microperfusion alterations after return of spontaneous circulation (ROSC) are associated with poor survival. To our knowledge, no human studies evaluating microperfusion during cardiopulmonary resuscitation (CPR) with simple and pre-hospital available tests have been published. Capillary refill time (CRT) and skin-mottling-score (SMS) are parameters for microperfusion and evaluated in septic and cardiogenic shock. In animal studies, microperfusion was impaired during cardiac arrest, although not correlating with systemic blood pressure.

The aim of this study is to investigate the correlation between impaired microcirculation (as measured with CRT and SMS) during resuscitation and ROSC resp. neurological outcome. Our clinical impression in daily routine is, that the appearance of a patient undergoing CPR is often linked to the outcome. We hypothesize, that this is due to changes in microperfusion of the skin.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Arrest With Successful Resuscitation; Cardiac Arrest; Cardiopulmonary Arrest; Cardiac Arrest, Out-Of-Hospital

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Vienna Municipal Emergency Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult out-of-hospital cardiac arrest patients

Description

Inclusion Criteria:

• All patients ≥18 years during cardiopulmonary resuscitation
• witnessed cardiac arrest

Exclusion Criteria:

• insufficient manpower (e.g. study team has to provide CPR)
• hypovolemia (exsanguination, anaphylaxis, sepsis as underlying cause)
• presumed or known COVID-19 disease
• hypo-/hyperthermia (<36.0°, >37.5°C)
• Raynaud's disease
• Peripheral arterial disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary refill time (CRT)	Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC	baseline (immediately after inclusion to the study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin mottling score (SMS)	Skin mottling score (Ait-Oufella, H., Lemoinne, S., Boelle, P.Y. et al. Mottling score predicts survival in septic shock. Intensive Care Med 37, 801-807 (2011). Best: 0 - no mottling to worst: 5 - mottling on the entire leg) for ROSC vs. noROSC	baseline (immediately after inclusion to the study = minute 0), minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first
Capillary blood lactate (Lac)	Capillary lactate in mmol/L from the capillary bed of a finger for ROSC vs noROSC and for correlations with CRT, SMS	baseline (immediately after inclusion to the study, = minute 0), minute 4, 8, 12, 16, 20
Hospital mortality	Correlation of CRT, SMS and Lac with hospital mortality	baseline (immediately after inclusion to the study)
Correlation of CRT, SMS and Lac and 30 days good neurological outcome	Good neurological outcome at 30 days measured with Cerebral Performance Category (CPC 1-5 (1 best: good cerebral performance, 5 worst: brain dead), modified Rankin scale (mRs 0-6 (0 best: no symptoms, 6 worst: dead) and health utility index 3 (HUI-3, worst: -0,36 - best: 1)	baseline (immediately after inclusion to the study)
Correlation of CRT, SMS and Lac and hospital discharge good neurological outcome	Good neurological outcome at hospital discharge measured with Cerebral Performance Category (CPC 1-5 (1 best: good cerebral performance, 5 worst: brain dead), modified Rankin scale (mRs 0-6 (0 best: no symptoms, 6 worst: dead) and health utility index 3 (HUI-3, worst: -0,36 - best: 1)	baseline (immediately after inclusion to the study)
Correlation of CRT/SMS and lactate	Correlation of CRT/SMS and lactate	baseline (immediately after inclusion to the study)
Correlation of SMS and CRT	Correlation of SMS and CRT	baseline (immediately after inclusion to the study)
Correlation of time since cardiac arrest and CRT/SMS/lactate	Correlation of time since cardiac arrest and CRT/SMS/lactate	baseline (immediately after inclusion to the study)
Correlation of catecholamine demand during the first 48 hours after ROSC and CRT/SMS	Cumulative catecholamine demand during the first 48 hours after ROSC in correlation with CRT/SMS/Lac during resuscitation	from ROSC up to 48 hours after ROSC
Capillary refill time (CRT)	Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC	minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Michael Holzer, MD, Department of Emergency Medicine, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: cardiopulmonary resuscitation; capillary refill time; skin mottling score; capillary lactate; microperfusion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No