Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans (NCT04332224) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans
Canada12 participantsStarted 2020-03-01
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* h…