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Prehospital Non-invasive Cooling of Comatose Patients After Cardiac Arrest

NCT03829215 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-05-08

No results posted yet for this study

Summary

Single centre randomized controlled two arm clinical trial of patients after out of hospital cardiac arrest with return of spontaneous circulation.

The trial objective is to investigate external cooling of cardiac arrest patients after cardiac arrest with the CAERvest cooling device.

After checking inclusion and exclusion criteria and immediately after return of spontaneous circulation, the CAERvest device will be filled and placed on the supine patient's chest. A recording oesophageal temperature probe will be inserted and connected to the defibrillator. Then the patient will be transported to the Emergency Department.

After admission to the emergency department, an additional endovascular cooling device will be placed and the patient will be cooled to 33°C for 24 hours (starting after reaching the target temperature range of under 34°C) with the endovascular cooling device.

Then the patient will be rewarmed at 0.25 °C/h. The CAERvest device will be removed, when a temperature below 34°C is reached.

After rewarming, the temperature will be controlled to be below 37.5°C for until 48 hours after cardiac arrest. After this time point pyrexia (core temperature above 37.5°C) will be treated with common pharmaceutical measures. Sedation, analgesia and relaxation will be discontinued at 36.5°C. Neurologic evaluation will be started not before 72 hours after cardiac arrest with a predefined evaluation protocol. During follow up the following secondary outcomes will be recorded: Survival to hospital discharge, survival to 30 days, survival to 6 months, best neurologic function within 30 days, best neurologic function within 6 months, and quality of life at 6 months.

Conditions

  • Cardiac Arrest
  • Postresuscitation Encephalopathy

Interventions

DEVICE

CAERVest cooling device

The CAERVest device will be filled and placed on the supine patient's chest immediately after return of spontaneous circulation. After admission to the emergency department, the device will be removed, when a temperature below 34°C is reached.

Sponsors & Collaborators

  • Bodychillz Ltd

    collaborator INDUSTRY

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Michael Holzer, M.D. · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829215 on ClinicalTrials.gov