Resuscitation and Capillary Reperfusion

Completed

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

• Registration Number: NCT04791995
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-02
• Study Start: 2021-03-03
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Primary Completion: 2022-03-31
• Study Completion: 2022-05-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Skin mottling score (SMS)	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	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
Correlation of catecholamine demand during the first 48 hours after ROSC and CRT/SMS	from ROSC up to 48 hours after ROSC	Cumulative catecholamine demand during the first 48 hours after ROSC in correlation with CRT/SMS/Lac during resuscitation
Correlation of CRT/SMS and lactate	baseline (immediately after inclusion to the study)	Correlation of CRT/SMS and lactate
Capillary refill time (CRT)	minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first	Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC
Capillary blood lactate (Lac)	baseline (immediately after inclusion to the study, = minute 0), minute 4, 8, 12, 16, 20	Capillary lactate in mmol/L from the capillary bed of a finger for ROSC vs noROSC and for correlations with CRT, SMS
Hospital mortality	baseline (immediately after inclusion to the study)	Correlation of CRT, SMS and Lac with hospital mortality
Correlation of CRT, SMS and Lac and 30 days good neurological outcome	baseline (immediately after inclusion to the study)	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)
Correlation of CRT, SMS and Lac and hospital discharge good neurological outcome	baseline (immediately after inclusion to the study)	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)
Correlation of SMS and CRT	baseline (immediately after inclusion to the study)	Correlation of SMS and CRT
Correlation of time since cardiac arrest and CRT/SMS/lactate	baseline (immediately after inclusion to the study)	Correlation of time since cardiac arrest and CRT/SMS/lactate

Trial Locations

Locations (1)

Vienna Municipal Emergency Service; 🇦🇹 Vienna, Austria