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临床试验/NCT02812069
NCT02812069撤回不适用

WarmSmart Warming Protocol

The Cleveland Clinic2 个研究点 分布在 1 个国家开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
volume plethysmography

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body-mass index 20-33 kg/m2;
  • Age 18-70 yrs;
  • ASA Physical Status 1-3.

排除标准

  • Serious skin lesions on the hands or arms;
  • History of serious vascular disease in the arms, including Raynaud's Syndrome;
  • Pre-operative fever or infection;
  • Surgery expected to be supine and in neutral position.

研究组 & 干预措施

minor to moderate surgical procedure

Other

The ThermaZone® Device will be used for 30 minutes to warm the cervical spine during

干预措施: ThermaZone® Device (Device)

结局指标

主要结局

volume plethysmography

时间窗: Recorded from the time the ThermaZone® Device is placed for 30 minutes to thirty minutes after it's removal at 10-minute intervals from the beginning of the initial observation period until the end of the post-warming recovery period.

mean-skin temperature

时间窗: Recorded from the time the ThermaZone® Device is placed for 30 minutes to thirty minutes after it's removal at 10-minute intervals from the beginning of the initial observation period until the end of the post-warming recovery period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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