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Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans

Primary Purpose

Body Temperature Changes

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Blanketrol cooling device and water-perfused blankets

Blanketrol and Kool Kit

Arctic Sun

About this trial

This is an interventional treatment trial for Body Temperature Changes focused on measuring brain cooling, medical body cooling devices, Brain protection, hypoxia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adults, who answer "No" to all the questions on a Get Active Questionnaire (GAQ) and the "Medical Screening Questionnaire for Hypothermia Study'.
Participants will also be interviewed to determine that they are free of any cardio- respiratory disease, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure.
Also, the study will include women of child bearing potential willing to use highly effective birth control during the trial. All women of child bearing potential will complete the "Research participant information for female subjects" and undergo a pregnancy test at screening.

Exclusion Criteria:

Anyone who gives a positive answer to any question in the GAQ or Medical Screening Questionnaire for Hypothermia Study, or who has any cardio-respiratory disease, renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure will be excluded.
Subjects contraindicated for meperidine administration or who have any of the conditions listed below will also be excluded from the study.
hypersensitivity to meperidine or any ingredients in the formulation
known or suspected mechanical GI obstruction or any diseases/conditions that affect bowel transit
suspected surgical abdomen (i.e. acute appendicitis or pancreatitis)
severe CNS depression, head injury, increased cerebrospinal or intracranial pressure
convulsive disorder, delirium tremens
hypothyroidism
prostatic hypertrophy or urethral stricture
sickle cell anemia
Addison's disease
Pheochromocitoma
Known sensitivity or intolerance to the drug metoclopramide
Use of medications that might interact negatively with meperidine. Examples should include MAO inhibitors at the time of screening or within 14 days of screening; CNS depressants; phenytoin; cimetidine; ritonavir; aclyclovir; skeletal muscle relaxants.
pregnant women, breastfeeding women, and women planning on becoming pregnant

Sites / Locations

211 Max Bell Centre, University of Manitoba

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-shivering cooling group

Arm Description

Cooling devices

Outcomes

Primary Outcome Measures

Esophageal temperature cooling rate

Rate at which esophageal temperature decreases

Skin heat exchange

Body surface heat flux

Secondary Outcome Measures

Full Information

NCT ID

NCT04332224

First Posted

March 26, 2020

Last Updated

January 19, 2023

Sponsor

University of Manitoba

1. Study Identification

Unique Protocol Identification Number

NCT04332224

Brief Title

Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans

Official Title

Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study compares three medical cooling devices for effectiveness of cooling the core of non-shivering subjects. This relates to common protocols to cool patients experiencing myocardial infarctions or stokes.

Detailed Description

Body core and brain cooling by 1-3°C has been used as an adjunct in treatment of stroke and myocardial infarction (MI) patients. Body surface cooling is simple and non-invasive however this process is difficult to implement effectively because skin cooling stimulates shivering heat production, a defense mechanism that protects the body core from cooling. It is sometimes necessary to pharmacologically inhibit shivering in order to cool the body from surface cooling strategies such as application of cold packs or cold water-perfused blankets or pads. Two commercial cooling units that are currently used are: 1) the Blanketrol III with standard Gel Pad (Gentherm Inc.); and 2) the Arctic Sun with hydrogel coated pads (Arctic Sun). A new cooling attachment system has been developed for the Blanketrol III. The new Kool Kit includes a head wrap, and a vest and lower body blanket. The effectiveness of the Kool Kit has not been quantified or compared to the current two systems mentioned above. Since shivering heat production attenuates core cooling, it must be eliminated in clinical or research settings where core cooling effectiveness is the main dependent variable. Previous studies from this laboratory (Laboratory for Exercise and Environmental Medicine) have used a human model for severe hypothermia which meperidine (Demerol) is infused to inhibit shivering. Under these conditions the primary core cooling capacity of a cooling system can be determined. The investigators intend to evaluate the Tco cooling rate, in hospital treatment conditions, [ambient temperature (Ta) = 22ºC] during surface cooling of non-shivering subjects with either: 1) Blanketrol with Gel Pads; 2) Blanketrol with Kool Kit; or 3) an Arctic Sun cooling system. The purpose is to compare the core cooling rates induced by three commercial surface cooling devices in non-shivering subjects. Because of the increased total surface area of the cooling pads and blankets, the investigators hypothesize that the Blanketrol with Kool Kit will have a greater rate of core cooling than the other two cooling systems tested.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Body Temperature Changes

Keywords

brain cooling, medical body cooling devices, Brain protection, hypoxia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Repeated measures design

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-shivering cooling group

Arm Type

Experimental

Arm Description

Cooling devices

Intervention Type

Device

Intervention Name(s)

Blanketrol cooling device and water-perfused blankets

Intervention Description

Blanketrol and water-perfused blankets

Intervention Type

Device

Intervention Name(s)

Blanketrol and Kool Kit

Intervention Description

Blanketrol cooling device with water-perfused vest, hood and lower body blanket

Intervention Type

Device

Intervention Name(s)

Arctic Sun

Intervention Description

Arctic Sun cooling device with gel cooling pads

Primary Outcome Measure Information:

Title

Esophageal temperature cooling rate

Description

Rate at which esophageal temperature decreases

Time Frame

120 minutes

Title

Skin heat exchange

Description

Body surface heat flux

Time Frame

120 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults, who answer "No" to all the questions on a Get Active Questionnaire (GAQ) and the "Medical Screening Questionnaire for Hypothermia Study'. Participants will also be interviewed to determine that they are free of any cardio- respiratory disease, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure. Also, the study will include women of child bearing potential willing to use highly effective birth control during the trial. All women of child bearing potential will complete the "Research participant information for female subjects" and undergo a pregnancy test at screening. Exclusion Criteria: Anyone who gives a positive answer to any question in the GAQ or Medical Screening Questionnaire for Hypothermia Study, or who has any cardio-respiratory disease, renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure will be excluded. Subjects contraindicated for meperidine administration or who have any of the conditions listed below will also be excluded from the study. hypersensitivity to meperidine or any ingredients in the formulation known or suspected mechanical GI obstruction or any diseases/conditions that affect bowel transit suspected surgical abdomen (i.e. acute appendicitis or pancreatitis) severe CNS depression, head injury, increased cerebrospinal or intracranial pressure convulsive disorder, delirium tremens hypothyroidism prostatic hypertrophy or urethral stricture sickle cell anemia Addison's disease Pheochromocitoma Known sensitivity or intolerance to the drug metoclopramide Use of medications that might interact negatively with meperidine. Examples should include MAO inhibitors at the time of screening or within 14 days of screening; CNS depressants; phenytoin; cimetidine; ritonavir; aclyclovir; skeletal muscle relaxants. pregnant women, breastfeeding women, and women planning on becoming pregnant

Facility Information:

Facility Name

211 Max Bell Centre, University of Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3T 2N2

Country

Canada

12. IPD Sharing Statement

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Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans

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