Cooling Vest May Reduce Heat Stress During Surgery

NCT04511208 | Completed Results FDA Device

• 1 other identifier: 20-214
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Self-rated Thermal Comfort.

  Immediately after surgery, while still gowned, surgeons will rate their thermal comfort on a 0-10 Likert scale, with 0 representing extreme cold, 5 being thermal comfort, and 10 representing extreme heat. Two points on the 11-point Likert scale will be considered a clinically important difference.

  Immediately after surgery, within 10 minutes

Secondary Outcomes (6)

• Mean Core Temperature.

  the sensor will be worn for a total of 90 minutes

• Mean Skin Temperature

  the sensor will be worn for a total of 90 minutes

• Surgeons' Cognitive Performance, Measured With the C3B Battery.

  Immediately after surgery, within 10 minutes

• Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale.

  Immediately after surgery, within 10 minutes

• Surgeon' Perceived Fatigue Measured as 0 Representing Not Fatigued at All, 5 Moderately Fatigued, and 10 Total Fatigue & Exhaustion

  Immediately after surgery, within 10 minutes

Study Arms (4)

Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA)

EXPERIMENTAL

Surgeons first performed one surgery with the cooling vest. On another day, they then performed one surgery without the cooling vest. Then on another day, they performed another surgery without the cooling vest. Then they finally performed one surgery with the cooling vest.

Device: Cooling Vest; Device: Without cooling vest

Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB)

EXPERIMENTAL

Surgeons first performed one surgery without the cooling vest. On another day, they then performed one surgery with the cooling vest. Then on another day, they performed another surgery with the cooling vest. Then they finally performed one surgery without the cooling vest.

Device: Cooling Vest; Device: Without cooling vest

Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB)

EXPERIMENTAL

Surgeons first performed one surgery with the cooling vest. On another day, they then performed another surgery with the cooling vest. Then on another day, they performed one surgery without the cooling vest. Then they finally performed another surgery without the cooling vest.

Device: Cooling Vest; Device: Without cooling vest

Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA)

EXPERIMENTAL

Surgeons first performed one surgery without the cooling vest. On another day, they then performed another surgery without the cooling vest. Then on another day, they performed one surgery with the cooling vest. Then they finally performed another surgery with the cooling vest.

Device: Cooling Vest; Device: Without cooling vest

Interventions

Cooling Vest DEVICE

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

Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB); Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA); Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB); Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA)

Without cooling vest DEVICE

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

Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB); Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA); Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB); Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Byrne JE, Rodriguez-Patarroyo FA, Mascha EJ, Han Y, Bravo M, Bloomfield MR, Rao SM, Sessler DI. Cooling vest improves surgeons' thermal comfort without affecting cognitive performance: a randomised cross-over trial. Occup Environ Med. 2023 Jun;80(6):339-345. doi: 10.1136/oemed-2022-108457. Epub 2023 May 4.

  PMID: 37142418 DERIVED

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Daniel Sessler, MD
• Organization: CCF

sseslerd@ccf.org

216-444-4900

Study Officials

• Daniel I Sessler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: August 13, 2020
• Study Start: August 25, 2020
• Primary Completion: December 9, 2020
• Study Completion: February 25, 2022
• Last Updated: July 28, 2022
• Results First Posted: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of the primary paper.
• Access Criteria: Collaborative proposal approved by the trial Executive Committee. Data use agreement will be required. Address requests to Daniel Sessler at DS@CCF.org.

Locations

US (1)