Hypothermia In Conscious Healthy Volunteers: a feasibility trial

Not Applicable

Completed

• Conditions: Stroke, acute myocardial infarction, cardiogenic shock; Circulatory System; Acute myocardial infarction

• Registration Number: ISRCTN50530495
• Lead Sponsor: Emergency Medical Cooling Systems (EMCOOL) AG (Austria)

Brief Summary

2011 results in https://pubmed.ncbi.nlm.nih.gov/22018242/ (added 23/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-04-30
• Study Start: 2011-09-05
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Volunteers aged 18 to 70 years

Exclusion Criteria

1. Pregnant women
2. Subjects with a known pre-existing cardiopulmonary disease or pre-existing malignancy
3. A pre-existing coagulopathy
4. An active dermatologic condition
5. Current treatment with monamineoxidase inhibitors
6. Previous or current drug abuse
7. Known allergy to the study medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Core temperature measured continuously with a temperature probe (Mon-a-therm® 9Fr/Ch; Tyco Healthcare, Mansfield, USA) advanced into the esophagus

Secondary Outcome Measures

Name	Time	Method
<br> 1. Comfort score recorded every 10 minutes during initial cooling, and every 30 minutes during maintenance cooling<br> 2. Shivering using a 4-point scale: 0 = no shivering evident; 1 = isolated facial or masticatory fasciculation; 2 = peripheral shivering; 3 = uncontrolled rigor<br> 3. Skin examination using a 5-points scale (severe - frost bites; moderate - skin trauma; medium - red skin; mild - pink skin; no visible skin irritation)<br>