S&B Heat Stress Pilot Protocols

Measuring the Effectiveness of a Personal Cooling Vest for the Prevention of Heat Strain in Construction Workers

The purpose of this study is to develop a heat stress program for the construction industry and evaluate its feasibility and appeal.

Study Overview

• Status: Completed
• Conditions: Thermal Discomfort
• Intervention / Treatment: Device: Group A; Device: Group B

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• employed at S&B
• work more than 20 hours a week

Exclusion Criteria:

• severe chronic disease (e.g. severe pulmonary or cardiovascular disease
• history of severe heat stroke
• use of a pacemaker
• any medical issue which would render the participant unable to wear a chest monitor and cooling vest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personal monitoring device and a cooling vest , Then personal monitoring device only	Device: Group A; The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group A will be fitted with a cooling and bio-harness. At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.
Experimental: Personal monitoring device only, Then personal monitoring device and a cooling vest	Device: Group B; The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group B will wear a bio-harness and no cooling vest.At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal discomfort as assessed by the thermal comfort scale	The thermal comfort scale is a 7-point scale that asks participants to rate their level of thermal comfort ranging from the sensation of "cold, cool, slightly cool, neutral, slightly warm, warm, hot	end of study (about 2 hours after start)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Heart rate as assessed by the Zephyr BioHarness 3.0 device	from baseline to end of study (2 hours after baseline)
Estimated core body temperature as assessed by the Zephyr BioHarness 3.0 device	from baseline to end of study (2 hours after baseline)
Respiratory rate as assessed by the Zephyr BioHarness 3.0 device	from baseline to end of study (2 hours after baseline)
Caloric burn as assessed by the Zephyr BioHarness 3.0 device	from baseline to end of study (2 hours after baseline)
Hydration status as indicated by urine specific gravity as assessed by a clinical refractometer analysis of urine sample	from baseline to end of study (2 hours after baseline)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute for Occupational Safety and Health (NIOSH/CDC)
• Investigators: Principal Investigator: William Perkison, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Actual): June 23, 2023
• Study Completion (Actual): June 23, 2023

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HSC-SPH-22-0651

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No