NCT02905708

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dr K Services PC · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Hypothermia

Interventions

Type	Name	Description
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.
DEVICE	Forced Air Warming Device	forced air-warming inflatable device applied according to standard hospital protocol.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-06-29
• Completion: 2017-08-31
• First posted: 2016-09-19
• Last updated: 2017-09-14

Locations

1 site across 1 country: United States