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Cooling Solutions for Outdoor Workers

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Stanford University

Status

Begins enrollment this month

Conditions

Hyperthermia
Heat Acclimation and Thermotolerance

Treatments

Other: Cooling glove
Behavioral: Standard Heat Illness Prevention Measures
Other: Cooling bandana

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers.

Full description

Workers in a variety of US industries-construction workers, welders, farmers, firefighters, and warehouse workers among them-are at risk for hyperthermia during work, yet very few interventions are being developed to mitigate heat related organ injury, particularly when workers do not have obvious symptoms of heat related illness. The investigators plan to test whether two active cooling technologies can help mitigate hyperthermia and risk for kidney injury. This work will enhance worker safety using evidence-based technology.

To accomplish the aims of testing two active cooling interventions, the investigators plan to implement a case-cross over randomized control trial design at the work site conducted in partnership with an employer and with 30 workers at risk for hyperthermia. Over three sequential weeks, the investigators will measure rate of core temperature change (primary outcome). Secondary outcomes will include changes in kidney injury markers; changes in worker productivity; and worker acceptability of interventions.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age ≥ 18
  2. Anticipated to be working in the same job category for the duration of the study
  3. Able to communicate in English or Spanish

Exclusion criteria

  1. Cannot provide informed consent
  2. Weight less than 40 kg
  3. Inability to swallow pills
  4. Known history of having a pacemaker or ICD
  5. Pregnancy as determined by self report and confirmed on Day 1
  6. Gastrointestinal disorders (e.g., gastroparesis, prior surgery on GI tract with the exception of appendectomy or cholecystectomy, diverticulosis or inflammatory bowel disease)
  7. Plan for an elective MRI in the 7 days post last planned pill ingestion

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 3 patient groups

Standard Heat Illness Prevention
Active Comparator group
Description:
Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks.
Treatment:
Behavioral: Standard Heat Illness Prevention Measures
Cooling bandana with Standard Heat Illness Prevention Measures
Experimental group
Description:
Provision of a bandana with slow-evaporation polymer for use during work, in addition to standard CAL-OSHA workplace heat illness prevention interventions
Treatment:
Other: Cooling bandana
Behavioral: Standard Heat Illness Prevention Measures
Cooling glove with standard Heat Illness Prevention
Experimental group
Description:
Provision of a glove with ability to circulate cool water, for use during breaks, in addition to standard CAL-OSHA workplace heat illness prevention interventions
Treatment:
Behavioral: Standard Heat Illness Prevention Measures
Other: Cooling glove

Trial contacts and locations

1

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Central trial contact

Shuchi Anand, MD; Catherine Ley, PhD

Data sourced from clinicaltrials.gov

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