Clinical trial NCT02905708: Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: normothermia
hypothermia
Lead sponsor: Dr K Services PC
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Core body temperature, degrees Centigrade
timeFrame: Peri-operative period - 15 minutes before surgery to 4 hours after termination of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
Study officials:
affiliation: Dr. K. Services P.C.
name: Laurence A Kirwan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandt S, Oguz R, Huttner 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 Dec 30.