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WarmSmart Warming Protocol

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ClinicalTrials.gov Identifier: NCT02812069
Recruitment Status : Withdrawn (Safety issue)
First Posted : June 23, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Hypothermia Device: ThermaZone® Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WarmSmart Warming Protocol
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
minor to moderate surgical procedure
The ThermaZone® Device will be used for 30 minutes to warm the cervical spine during
Device: ThermaZone® Device
The device will be used to intraoperatively warm patients having minor-to moderate surgical procedures




Primary Outcome Measures :
  1. volume plethysmography [ Time Frame: 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. ]
  2. mean-skin temperature [ Time Frame: 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812069


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Study Chair: Daniel Sessler, M.D. The Cleveland Clinic
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02812069    
Other Study ID Numbers: 15-942
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes