Norwalk Hospital
Norwalk, Connecticut, 06856, United States
NCT Number: NCT02905708
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
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Norwalk, Connecticut, 06856, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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.
Other names: Garment with heat packs - iron powder and activated charcoal
forced air-warming inflatable device applied according to standard hospital protocol.
Other names: forced air-warming device
Time frame: Peri-operative period - 15 minutes before surgery to 4 hours after termination of surgery.
Measurement of core body temperature, degrees Centigrade, 15 minutes intervals during above time frame.
Dr K Services PC
Other
Efficacy Warming Garment to Maintain Normothermia Using Integrated Chemical Heat Pack Construction, in the Perioperative Period, for Surgery Less Than 12 Hours Duration
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06485427
Acute Ischemic Stroke, Body Temperature Changes
Lanzhou, Gansu, China
View Trial DetailsNCT04011462
Body Temperature Changes, Hypothermia
São Paulo, Brazil
View Trial DetailsNCT04975867
Body Temperature Changes, Carbon Monoxide Poisoning
Wŏnju, Gangwon-do, South Korea
View Trial DetailsNCT07505654
Body Temperature Changes, Hypothermia
Edirne, Turkey (Türkiye)
View Trial Details