Clinical Trials Logo

Clinical Trial Summary

Our goal is to evaluate the efficacy of the Westmed system vs the Bair Hugger Blanket.


Clinical Trial Description

Temperature management is an important aspect of perioperative care that falls under the purview of the anesthesiologist. Temperature is recognized as one of four primary vital signs and significant deviations from normal values may result in patient harm. General anesthesia disrupts the body's temperature homeostasis by inhibiting temperature regulation mechanisms such as vasoconstriction/-dilation, shivering and behavioral interventions (donning clothes or leaving an area with excessive heat, for example). Anesthetized patient have a tendency to become hypothermic, especially during long surgical procedures. This results from both the redistribution of cooler peripheral temperatures into the core (due to vasodilation) as well as actual temperature loss to a cold operating room environment (which is maintained at a lower temperature for the comfort of fully gowned surgeons and nurses). In addition, large surgical incisions predispose the patient to hypothermia through evaporation and convection. Hypothermia is a recognized risk factor that predisposes the patient to an increased metabolic rate, increased oxygen demand, coagulopathies, impaired wound healing, impaired immune function and increased risk of infection. Therefore, maintenance of normal body temperature is an important goal of every general anesthetic - and is a well-accepted quality metric associated with patient care. Because of the greater surface area to volume relationship, children are thought to be a greater risk of intraoperative hypothermia. The most widely used method of maintaining body temperature during surgery (and a routine at this institution) is by using a forced-air warming blanket (Bair Hugger warming blanket, 3M). Despite its widespread use, the forced-air warming blanket has its limitations. For example, during certain surgical procedures, the location of the surgical field precludes placement of the warming blanket. In addition, the warming blanket often cannot be placed immediately after the induction of anesthesia (when complex patient positioning is required) - leaving the patient exposed to hypothermic conditions for short (10-15min) or long (30-60min) periods of time. There is hence a need for alternative warming systems that could be implemented immediately following anesthetic induction. Westmed, Inc. has developed an alternative system that utilizes a heated, humidified breathing circuit to regulate a patient's body temperature in the intraoperative setting. This system is active from the moment the trachea is intubated following anesthetic induction, i.e. there are no delays in instituting thermal management. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03896867
Study type Interventional
Source University of Minnesota
Contact Benjamin Kloesel, MD
Phone 612-625-6659
Email bkloesel1@umn.edu
Status Recruiting
Phase N/A
Start date October 31, 2019
Completion date October 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT04355013 - Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods
Recruiting NCT04776954 - Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery N/A
Recruiting NCT05692947 - The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes N/A
Active, not recruiting NCT05344300 - Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases
Completed NCT04057612 - Correlation Between Core Temperature and Skin Temperature in Pediatrics
Terminated NCT03876808 - The Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities N/A
Recruiting NCT04654429 - Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients? Phase 4
Terminated NCT04489927 - Validation of the Measurement Accuracy of the Tcore Thermometer
Completed NCT04097249 - Infrared Thermography for the Diagnosis of Musculoskeletal Pain
Completed NCT06065332 - Post-Procedural Biotech Cellulose Mask N/A
Enrolling by invitation NCT04217434 - Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial N/A
Recruiting NCT05203809 - Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies
Completed NCT05136482 - Skin Temperature Changes When Using a Cryocompression Device N/A
Completed NCT04968080 - A Study to Validate Comparability of an Infrared Thermographic Camera Versus Oral, Forehead, and Ear Thermometers When Determining Body Temperature in Adult Participants
Completed NCT04608565 - Remote Biomonitoring (RBM) for Temperature Surveillance of Mothers and Newborns: Pre-clinical and Clinical Evaluation N/A
Completed NCT05705206 - Feasibility and Accuracy of Core Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device in Pediatrics
Completed NCT04317378 - Increase in Temperature in Children Undergoing MRI
Completed NCT04252820 - Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia N/A
Completed NCT03820232 - Intraoperative Body Core Temperature Monitoring: Oesophageal Probe vs Heated Controlled Servo Sensor
Recruiting NCT05972187 - The Effect of IEQ on Cognition and Health N/A