N/A
N=30
Cooling Vest May Reduce Heat Stress During Surgery
Body Temperature Changes
Bottom Line
View on ClinicalTrials.gov: NCT04511208 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Self-rated Thermal Comfort. — 4.4; 6.6 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cooling Vest (Device); Without cooling vest (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-rated Thermal Comfort. |
4.4; 6.6 | <0.001 sig |
| SECONDARY Mean Core Temperature. |
32.9; 33.2 | 0.006 sig |
| SECONDARY Mean Skin Temperature |
36.1; 36.3 | 0.046 sig |
| SECONDARY Surgeons' Cognitive Performance, Measured With the C3B Battery. |
69.4; 69.4; 58.3; 57.7 | 0.955 |
| SECONDARY Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale. |
13; 13 | 0.007 sig |
| SECONDARY Surgeon' Perceived Fatigue Measured as 0 Representing Not Fatigued at All, 5 Moderately Fatigued, and 10 Total Fatigue & Exhaustion |
2.3; 3.3 | 0.004 sig |
| SECONDARY Surgeons' Perception and Amount of Sweat-soaked Scrub Clothing. |
1.4; 4.4 | <0.001 sig |
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 to 1 of 4 sequences: ABBA, BAAB, AABB or BBAA. The design is "uniform" in that each treatment appears the same number of times within each sequence (uniform within sequence) and if each treatment appears the same number of times within each period (uniform within each period). It is strongly balanced with respect to first-order carryover effects because each treatment precedes every other treatment, including itself, the same number of times
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04511208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.