Clinical Trials Logo

Clinical Trial Summary

Hypothermia during surgery and in the postoperative period is associated with adverse outcomes including impaired drug metabolism, cardiac morbidity, shivering, impaired immune function, coagulopathy, and increased use of hospital resources. Several clinical studies have demonstrated that maintenance of normothermia during the perioperative period significantly reduces morbidity.

Mercury Biomed has developed a patient-warming system, WarmSmart, that potentially transfers adequate heat through hands and feet based on the physiological principle of peripheral arterio-venous shunt vaso-dilation. The technology works as a two-step process by selective thermal stimulation along the spinal cord to up-regulate blood flow to arterio-venous shunts and triggering arterio-venous shunt vasodilation and by applying circulating water heat exchangers to the palmar and plantar glabrous skin to warm highly perfused shunts in that area.

General anesthesia reduces the vasoconstriction threshold (triggering core temperature) by 1-2°C, thus promoting arteriovenous shunt dilation. It remains unknown, though, whether cervical spine warming further augments arterio-venous shunt dilation during general anesthesia. If spine heating proves unnecessary under anesthesia, Mercury Biomed's WarmSmart warming could be simpler and less expensive. Investigators therefore propose to test the hypothesis that cutaneous heating near the cervical spine does not further augment arterio-venous flow in fingers during general anesthesia.

Investigators propose to enroll ten patients. The patients will be pre-warmed and warmed intraoperatively with forced-air to maintain a core temperature near 36°C.

A ThermaZone® Device capable of heating the cervical spine area will be positioned behind the patient's neck upon arrival in the operating rooms. Additionally a forced-air warmer will be positioned appropriately and activated as soon as practical, usually after prepping and draping. Ambient temperature will be maintained near 20°C.

After about one hour of anesthesia when temperature and other factors are stable, investigators will start a 30-minute observation period. Thereafter investigators will activate the cervical spine warming system for 30 minutes (warming measurement period) and thereafter have a 30 minutes control period again.

Measurements will be recorded such as mean-skin temperature, distal esophageal temperature, MAC fraction, mean-arterial pressure and finger blood flow.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02812069
Study type Interventional
Source The Cleveland Clinic
Contact
Status Withdrawn
Phase N/A
Start date September 2015
Completion date July 17, 2017

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
Not yet recruiting NCT02211703 - National Epidemiologic Survey on the Incidence of Perioperative Hypothermia N/A
Completed NCT02742818 - Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models N/A
Completed NCT02121574 - Accuracy of Zero-flux and Ingestible Thermometers N/A
Completed NCT02177903 - Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes N/A
Recruiting NCT01866384 - Targeted Temperature Management After Intracerebral Hemorrhage Phase 2
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01793337 - Core Body Temperature Measurement During Hot and Cold Environmental Exposure N/A
Completed NCT01722955 - Pre-warmed Intravenous Fluids and Monitored Anesthesia Care 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
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Completed NCT00904228 - Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room N/A
Completed NCT00334360 - Dexmed/Buspirone Synergism on Shivering Phase 4
Completed NCT04399902 - Study to Actively Warm Trauma Patients N/A
Completed NCT03450668 - mOm Incubator Pilot Study N/A
Recruiting NCT04975867 - Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning N/A