Skip to main content
OpenTrials
Completed

NCT Number: NCT02905708

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Air-Activated heating packs

Device

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

Forced air warming device

Device

forced air-warming inflatable device applied according to standard hospital protocol.

Other names: forced air-warming device

Primary outcomes

  1. Core body temperature, degrees Centigrade

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr K Services PC

Other

Registry information

Official study title

Efficacy Warming Garment to Maintain Normothermia Using Integrated Chemical Heat Pack Construction, in the Perioperative Period, for Surgery Less Than 12 Hours Duration

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2016
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.