WarmSmart Warming Protocol
Primary Purpose
Hypothermia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ThermaZone® Device
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia
Eligibility Criteria
Inclusion Criteria:
- Body-mass index 20-33 kg/m2;
- Age 18-70 yrs;
- ASA Physical Status 1-3.
Exclusion Criteria:
- 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.
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
minor to moderate surgical procedure
Arm Description
The ThermaZone® Device will be used for 30 minutes to warm the cervical spine during
Outcomes
Primary Outcome Measures
volume plethysmography
mean-skin temperature
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02812069
Brief Title
WarmSmart Warming Protocol
Official Title
WarmSmart Warming Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Safety issue
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
minor to moderate surgical procedure
Arm Type
Other
Arm Description
The ThermaZone® Device will be used for 30 minutes to warm the cervical spine during
Intervention Type
Device
Intervention Name(s)
ThermaZone® Device
Intervention Description
The device will be used to intraoperatively warm patients having minor-to moderate surgical procedures
Primary Outcome Measure Information:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body-mass index 20-33 kg/m2;
Age 18-70 yrs;
ASA Physical Status 1-3.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Sessler, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
WarmSmart Warming Protocol
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