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WarmSmart Warming Protocol

Primary Purpose

Hypothermia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ThermaZone® Device
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

First Posted
May 19, 2016
Last Updated
October 9, 2018
Sponsor
The Cleveland Clinic
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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Withdrawn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

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WarmSmart Warming Protocol

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