Hypothermia In Conscious Healthy Volunteers: a feasibility trial

Surface cooling for induction of mild Hypothermia In Conscious Healthy Volunteers: a feasibility trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50530495

Enrollment

Registered

2011-09-05

Start date

2011-03-01

Completion date

Unknown

Last updated

2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, acute myocardial infarction, cardiogenic shock Circulatory System Acute myocardial infarction

Interventions

Volunteers with an age of 18 to 70 years are included. After baseline measurements, meperidine (Alodan®, Gerot, Vienna, Austria) 1 mg/kg bolus, followed by 30 mg/h intravenously, and buspirone (Buspar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Volunteers aged 18 to 70 years

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026