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Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia

Sponsor
Dr K Services PC (Other)
Overall Status
Completed
CT.gov ID
NCT02905708
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative, Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack Construction, With a View to Maintaining Normothermia During the Peri-operative Period

Condition or Disease Intervention/Treatment Phase
  • Device: Air-Activated heating packs
  • Device: Forced Air Warming Device
 N/A

Detailed Description

Subjects will be randomized into two groups. The first group will have the standard warming devices currently used which consists of a forced air warming device. This will be applied in the form of a gown in the pre-operative area. The device is called the Bair Paws. (Subjects will either continue with this or have a separate forced air warming device applied in the operating room called a Bair Hugger.) This device is non experimental and is FDA approved and used within the hospital to keep patients warm. They will then have their temperature taken and documented by the staff at various prescribed times.

The second group will receive the warming devices being studied which consist of a jacket, pants, gloves and socks with integrated air-activated chemical heat packs. The garment is applied at least twenty minutes prior to surgery. The same warming device will be maintained in place throughout the surgery and the period of post-anesthesia.

Intraoperative period: The participants temperature will be monitored and documented at prescribed times.

Postoperative period: The participants will have temperature monitored in the post anesthesia care area. Your part in this study will last until you are admitted to your room after surgery or you change into your own clothes prior to discharge.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy Warming Garment to Maintain Normothermia Using Integrated Chemical Heat Pack Construction, in the Perioperative Period, for Surgery Less Than 12 Hours Duration
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Jun 29, 2017
Actual Study Completion Date :
Aug 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Forced Air Warming Device

Active Comparator: Forced Air Warming Device first group will have the warming devices started in the pre-operative area. You will receive a full body forced air warming. Device is non experimental and FDA approved, used within the hospital to keep patients warm.You will then have your temperature taken and documented by the staff at various prescribed times. Warming in the operating room: You will receive the same or a similar warming device known as a Bair Hugger and warmed IV fluids once you are in the operating room. Bair Paws or Bair Hugger will also be used in the post-anesthesia care area.

Device: Forced Air Warming Device
forced air-warming inflatable device applied according to standard hospital protocol.
Other Names:
  • forced air-warming device

    		•
    Active Comparator: Air-Activated heating packs

    The second group will receive the study warming device which consists of a jacket, pants, gloves and socks with integrated Air-Activated heating packs. Device is supplied vacuum packed, heat packs of iron powder/activated charcoal activated by air. Device applied at least twenty minutes prior to surgery. The same device will be maintained in place throughout the surgery and the post-anesthesia period.

    Device: Air-Activated heating packs
    The subject disrobe and will dress in a jacket, pants, gloves and socks (ensemble) which will be removed from a vacuum pack. He will be assisted by the nurse in pre-operative area. The ensemble will remain in place until the subject is fully recovered from anesthesia.
    Other Names:
  • Garment with heat packs - iron powder and activated charcoal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Core body temperature, degrees Centigrade [Peri-operative period - 15 minutes before surgery to 4 hours after termination of surgery.]

      Measurement of core body temperature, degrees Centigrade, 15 minutes intervals during above time frame.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Male Female ASA physical status classification system Class I ASA physical status classification system Class II Age 18-80

    Exclusion Criteria:

    ASA physical status classification system Class III -VI Body Mass Index greater than 37.0

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Norwalk Hospital Norwalk Connecticut United States 06856

    Sponsors and Collaborators

    • Dr K Services PC

    Investigators

    • Principal Investigator: Laurence A Kirwan, M.D., Dr. K. Services P.C.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr K Services PC
    ClinicalTrials.gov Identifier:
    NCT02905708
    Other Study ID Numbers:
    • DrKirwan IRB#16-11
    First Posted:
    Sep 19, 2016
    Last Update Posted:
    Sep 14, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Dr K Services PC
    normothermia
    hypothermia
    Additional relevant MeSH terms:
    Hypothermia
    Charcoal

    Study Results

    No Results Posted as of Sep 14, 2017