NCT02685176

Brief Summary

This Clinical trial is being conducted to study the effectiveness of heat donation through head or torso in hypothermic rewarming efficacy using a human model for severe hypothermia. The purpose of the study is to compare the core rewarming effectiveness of the same amount of heat donation through the head or torso in treatment of hypothermia using a human model for severe hypothermia. The information obtained from this study will give a better understanding of heat-transfer mechanisms. This might help in the ongoing research in hypothermia treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

March 1, 2019

Status Verified

March 1, 2018

Enrollment Period

2.1 years

First QC Date

February 12, 2016

Last Update Submit

February 28, 2019

Conditions

Keywords

hypothermiarewarmingnon-shivering

Outcome Measures

Primary Outcomes (1)

  • Rewarming Rate

    Rate of core temperature increase during rewarming

    120 minutes

Study Arms (3)

No Heat

EXPERIMENTAL

No active heating will be provided post cooling

Other: No heat

Head

EXPERIMENTAL

Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the head following cooling

Device: Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)

Torso

EXPERIMENTAL

Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the torso following cooling

Device: Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)

Interventions

A heater (STK Heatpac) will be used in the active warming arms of the study.

HeadTorso
No heatOTHER

No active heating provided post cooling

No Heat

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults, who answer "No" to all the questions on a Physical Activity Readiness Questionnaire (PAR-Q). Participants will also be interviewed to determine if they have any cardio-respiratory diseases, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure.

You may not qualify if:

  • A positive answer to any PAR-Q question, or any cardio-respiratory diseases, Renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gordon G Giesbrecht, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 18, 2016

Study Start

September 1, 2016

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

March 1, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations