Ignite Creation Date:
2024-05-06 @ 9:07 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02905708
Status:
COMPLETED
Last Update Posted:
2017-09-14
First Post:
2016-09-06
Brief Title:
Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia
Sponsor:
Dr K Services PC
Organization:
Dr K Services PC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None