WarmSmart Warming Protocol

Status Withdrawn

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

Hypothermia

Clinical Trial Details

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

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
Completed	`NCT02177903` - Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes	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
Completed	`NCT02742818` - Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models	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
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
Completed	`NCT03450668` - mOm Incubator Pilot Study	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.