NCT04332224

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 23, 2023

Status Verified

March 1, 2021

Enrollment Period

2.2 years

First QC Date

March 26, 2020

Last Update Submit

January 19, 2023

Conditions

Body Temperature Changes

Keywords

brain coolingmedical body cooling devicesBrain protectionhypoxia

Outcome Measures

Primary Outcomes (2)

  • Esophageal temperature cooling rate

    Rate at which esophageal temperature decreases

    120 minutes

  • Skin heat exchange

    Body surface heat flux

    120 minutes

Study Arms (1)

Non-shivering cooling group

EXPERIMENTAL

Cooling devices

Device: Blanketrol cooling device and water-perfused blanketsDevice: Blanketrol and Kool KitDevice: Arctic Sun

Interventions

Blanketrol cooling device and water-perfused blanketsDEVICE

Blanketrol and water-perfused blankets

Non-shivering cooling group
Blanketrol and Kool KitDEVICE

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

Non-shivering cooling group
Arctic SunDEVICE

Arctic Sun cooling device with gel cooling pads

Non-shivering cooling group

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 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

211 Max Bell Centre, University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • Leclerc C, Talebian Nia M, Giesbrecht GG. Heat Transfer Capabilities of Surface Cooling Systems for Inducing Therapeutic Hypothermia. Ther Hypothermia Temp Manag. 2023 Sep;13(3):149-158. doi: 10.1089/ther.2023.0003. Epub 2023 Jun 5.

    PMID: 37276032DERIVED

MeSH Terms

Conditions

Body Temperature ChangesHypoxia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Respiratory

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Repeated measures design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

April 2, 2020

Study Start

March 1, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

January 23, 2023

Record last verified: 2021-03

Locations

CA(1)