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CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.

NCT02030236 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-03-04

No results posted yet for this study

Summary

Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain function after return of spontaneous circulation when someone has been resuscitated from cardiac arrest. Cardiac arrest is a form of heart attack where the heart stops pumping.

The device is a prototype cooling vest. The investigators anticipate that this will be useful in ambulances, helicopters and emergency departments where there is a need for a portable, safe, easy-to-use, inexpensive, external, effective, readily-controlled and single-patient use device able to reduce body temperature by at least 1 degree Centigrade an hour to initiate cooling. What the investigators are doing in these trials is to demonstrate that the investigators can cool people and to get the best design possible for patient use. That means some of the initial prototypes will not resemble what we expect the eventual device to look like. The investigators will be undertaking the initial trials on 30 normal volunteers.

Conditions

  • Hypothermia.

Interventions

DEVICE

Cooling

Temperature reached Duration of exposure to cold.

Sponsors & Collaborators

  • Bodychillz Ltd

    lead INDUSTRY

Principal Investigators

  • Rowland L Cottingham, FRCS FCEM · Brighton and Sussex Universities Hospital NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United Kingdom

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 NCT02030236 on ClinicalTrials.gov