CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Cooling Vest +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04511208
NCT04511208N/ACompleted

Cooling Vest May Reduce Heat Stress, Improve Thermal Comfort, and Preserve Cognitive Performance of Surgeons While Performing Surgery

The Cleveland Clinic·interventional·Posted Aug 13, 2020·Updated Jul 28, 2022

In Brief

A clinical study evaluating Cooling Vest and Without cooling vest for Body Temperature Changes. Completed, enrolled 30 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 13, 2020
Enrollment StartAug 25, 2020
Primary CompletionDec 9, 2020
Study CompletionFeb 25, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.9 years ago

Interventions

Cooling Vestdevice

Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.

Without cooling vestdevice

Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.