Clincosm LogoSign in Get a demo

Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes

Sponsor
3M (Industry)
Overall Status
Completed
CT.gov ID
NCT02177903
Collaborator
(none)
220
Enrollment
1
Location
2
Arms
15
Duration (Months)
14.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.

Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:

  • Increased comfort in the pre-operative period by being warmer

  • Decreased incidence of mild hypothermia

  • Possible decreased incidence of transfusion with less bleeding

  • Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)

  • Possible shorter stay in the PACU and overall Length of Stay (LOS)

  • Possible decreased risk for surgical site infection

Condition or Disease Intervention/Treatment Phase
  • Device: Bair Paws Patient Adjustable Warming System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: Bair PawsPatient Adjustable Warming System

Bair PawsPatient Adjustable Warming System for active pre-warming

Device: Bair Paws Patient Adjustable Warming System
Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
Other Names:
  • Bair Paws Flex Gown

    		•
    Other: Passive pre-warming

    Passive pre-warming

    Device: Bair Paws Patient Adjustable Warming System
    Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
    Other Names:
  • Bair Paws Flex Gown

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of hypothermia [Up to 12 hours, until PACU discharge]

      The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Elective or "urgent" surgery under general anesthesia

    • ≥19 years but ≤85 years of age

    • Able to provide informed consent.

    Exclusion Criteria:

    • Refusal of Informed consent

    • Metabolic derangement/drug therapy already affecting thermal homeostasis

    • Preexisting hypothermia (<35.5 degreeC) or hyperthermia (>37.5 degreeC) (oral)

    • Surgical procedure anticipated to be longer than 6 hours or less than 1 hour

    • Emergency (category 1a) Surgery

    • Patients undergoing exclusively spinal or epidural anesthesia

    • Patients receiving aortic cross-clamping

    • Patients receiving transdermal medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Columbian Hospital Vancouver British Columbia Canada V3L 3W7

    Sponsors and Collaborators

    • 3M

    Investigators

    • Principal Investigator: Richard Merchant, MD, Staff Anesthesiologist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    3M
    ClinicalTrials.gov Identifier:
    NCT02177903
    Other Study ID Numbers:
    • EM-05-013093
    First Posted:
    Jun 30, 2014
    Last Update Posted:
    Sep 1, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by 3M
    hypothermia
    surgical site infection
    opioid usage
    blood loss
    pain severity
    anxiety
    Length of Stay
    Additional relevant MeSH terms:
    Hypothermia

    Study Results

    No Results Posted as of Sep 1, 2016