WarmSmart Warming Protocol
| Status: | Withdrawn |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/13/2018 |
| Start Date: | September 2015 |
| End Date: | July 17, 2017 |
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.
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.
Inclusion Criteria:
1. Body-mass index 20-33 kg/m2;
2. Age 18-70 yrs;
3. ASA Physical Status 1-3.
Exclusion Criteria:
1. Serious skin lesions on the hands or arms;
2. History of serious vascular disease in the arms, including Raynaud's Syndrome;
3. Pre-operative fever or infection;
4. Surgery expected to be supine and in neutral position.
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