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

Hypothermia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905708
• Other study ID #: DrKirwan IRB#16-11
• Status: Completed
• Phase: N/A
• First received: September 6, 2016
• Last updated: September 13, 2017
• Start date: December 1, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: Dr K Services PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 31, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

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

Locations

Country	Name	City	State
United States	Norwalk Hospital	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Dr K Services PC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brandt S, Oguz R, Hüttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core body temperature, degrees Centigrade	Measurement of core body temperature, degrees Centigrade, 15 minutes intervals during above time frame.	Peri-operative period - 15 minutes before surgery to 4 hours after termination of surgery.