Intraoperative Warming Comparison of Devices

Status Completed

Clinical Trial Summary

Hypothermia is a common and serious complication during anesthesia and surgery. Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and exposure to cold operating room environment.

Various warming methods, such as warm blankets, forced-air warmers and circulating water mattresses, are currently used to prevent and treat mild perioperative hypothermia. All are cutaneous approaches that rely on heating the peripheral tissues in order to increase the thermal core temperature. Application of cutaneous warming system blankets/pads are limited by location/extent of operative site; for example, in certain procedures such as laparatomies, reconstructive plastic surgery or orthopedic surgery, only a limited amount of skin surface is available for warming application. The Dynatherm vitalHEAT technology takes advantage of the body's natural thermoregulatory system to channel thermal energy to the body's core non-invasively at a rapid rate. The vital heat (vH2) system is designed to treat hypothermia during the peri-operative period through a combination of localized heat and vacuum application to one hand & forearm; this application 1) opens the arteriovenous anastamoses located in the palm of the hand and 2) conductively warms the extremity thus effectively warming the blood flow to the body's core. The vital heat vH2 system is a portable and compact warming device which provides a non-invasive approach to warming patients during surgery.

The primary objective of this study is to determine if the Dynatherm Medical vitalHEAT (vH2) Temperature Management System is as effective as the forced-air warming Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) for maintenance of intraoperative body temperature in patients undergoing abdominal surgery under general anesthesia. The critical endpoints to be evaluated in making this determination are 1) % of subjects with an average intraoperative esophageal temperature of ≥ 36º C and 2) % of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C. Secondary objectives include 1) comparison of the core body temperatures @ 60 minutes post anesthesia induction, 2) comparison of temperature trends during surgery and 3) comparison of the subjects' post anesthesia care unit temperature trends and hypothermic symptoms such as shivering.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Hypothermia

Clinical Trial Details

NCT number	NCT00650260
Study type	Interventional
Source	University of South Florida
Contact
Status	Completed
Phase	N/A
Start date	February 2009
Completion date	August 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05669313` - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Not yet recruiting	`NCT05306392` - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation	N/A
Completed	`NCT02685176` - Head and Torso Rewarming Using a Human Model for Severe Hypothermia	N/A
Completed	`NCT02586974` - Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response	N/A
Withdrawn	`NCT02812069` - WarmSmart Warming Protocol	N/A
Completed	`NCT02177903` - Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes	N/A
Completed	`NCT02742818` - Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models	N/A
Not yet recruiting	`NCT02211703` - National Epidemiologic Survey on the Incidence of Perioperative Hypothermia	N/A
Completed	`NCT02121574` - Accuracy of Zero-flux and Ingestible Thermometers	N/A
Recruiting	`NCT01866384` - Targeted Temperature Management After Intracerebral Hemorrhage	Phase 2
Active, not recruiting	`NCT01529658` - Renal Hypothermia During Partial Nephrectomy	N/A
Completed	`NCT01722955` - Pre-warmed Intravenous Fluids and Monitored Anesthesia Care	N/A
Completed	`NCT01793337` - Core Body Temperature Measurement During Hot and Cold Environmental Exposure	N/A
Completed	`NCT01559675` - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery	N/A
Terminated	`NCT01018576` - Delayed Cord Clamping in Premature Infants	N/A
Completed	`NCT00904228` - Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room	N/A
Terminated	`NCT00822796` - Thermogard™ Efficacy Trial	N/A
Completed	`NCT00334360` - Dexmed/Buspirone Synergism on Shivering	Phase 4
Not yet recruiting	`NCT06283771` - The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering	N/A
Completed	`NCT04399902` - Study to Actively Warm Trauma Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.