Status:
COMPLETED
Cooling Vest May Reduce Heat Stress During Surgery
Lead Sponsor:
The Cleveland Clinic
Conditions:
Body Temperature Changes
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
The investigators will propose a randomized cross-over trial using a uniform and strongly balanced 4-period design in which will include four operations for each surgeon. Surgeons will be randomized t...
Detailed Description
The subjects will be randomly assigned to use either the CoolSource™ cooling vest (worn between scrubs) and a conventional surgical gown for each of 4 surgeries. Sequence of treatments within the subj...
Eligibility Criteria
Inclusion
- Surgeons who perform elective major orthopedic surgery such as total hip and knee arthroplasties scheduled for 90 to 150 minutes at the Cleveland Clinic Main Campus.
- Orthopedic surgeons ages of 25-65 years old, as body temperatures may be lower and less stable in the elderly (Waalen \& Buxbaum, 2011), who operate frequently enough to participate in four cross-over cases.
- Surgical helmet system is consistently worn for each of the surgeon's four cases, if used in the first case.
Exclusion
- Surgical cases that require surgeons to sit on stools during the procedure, which may impact temperature and energy expenditure.
- \- Surgeons who report having a recent illness within 24 hours prior to the surgery, symptoms producing a febrile condition;
- Surgeons who worked the previous evening.
- Surgeons who wear lead X-ray gowns.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04511208
Start Date
August 25 2020
End Date
February 25 2022
Last Update
July 28 2022
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195