Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/15/2017 |
| Start Date: | December 1, 2016 |
| End Date: | August 31, 2017 |
Efficacy Warming Garment to Maintain Normothermia Using Integrated Chemical Heat Pack Construction, in the Perioperative Period, for Surgery Less Than 12 Hours Duration
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
Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack
Construction, With a View to Maintaining Normothermia During the Peri-operative Period
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.
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.
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
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