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Cooling Vest May Reduce Heat Stress During Surgery

NCT04511208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-28

Study results available
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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

Conditions

  • Body Temperature Changes

Interventions

DEVICE

Cooling Vest

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

DEVICE

Without cooling vest

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Daniel I Sessler, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2020-12-09
Completion
2022-02-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04511208 on ClinicalTrials.gov