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Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study

Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study, Institutional Review Board# 1801201082

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03429348
Enrollment
28
Registered
2018-02-12
Start date
2018-04-04
Completion date
2020-02-28
Last updated
2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-fire Rehabilitation of Firefighters in Sauna

Keywords

Firefighter, Post-Fire Rehabilitation, Sauna

Brief summary

Firefighters are at increased risk of cancer, and both inhalation and dermal routes contribute to overall exposure to carcinogens, including polycyclic aromatic hydrocarbons (PAHs). The purpose of the current study is to determine if post-fire firefighter rehabilitation in an infrared sauna: a) affects absorption of PAHs as measured by urinary metabolites; and b) changes core body temperature and heart rate.

Detailed description

An initial four firefighters will be evaluated for change in PAHs associated with standard fire department flashover training to determine if urinary PAH metabolites increase following exposure, comparing baseline urine samples (collected for up to 12 hours before the training fire) to a repeat urine sample (collected up to 12 hours after cessation of the training fire.) If a significant increase is not seen, then repeat testing with four firefighters will be completed using burn room training scenarios. Air monitoring during the training periods may be carried out with standard industrial hygiene instruments. Stage 2: Once a significant increase in PAHs has been documented, the associated training scenario (flashover training or alternate live fire training), testing will be carried out in 20 subjects. Prior to starting the training scenario, the firefighters will provide a urine sample (collected over a time period of 12 hours prior to the training fire), swallow a core temperature probe and wear a monitor for recording both their core temperature and heart rate. In addition, dermal wipes will be collected prior to the training fire. Air monitoring during the training periods will be carried out with standard industrial hygiene instruments. Following cessation of the training scenario, the subjects will follow their standard fire department procedures, which may involve using skin wipes and showering. The subjects will then be randomized to either an infrared sauna treatment, with or without exercising as determined by the fire department protocol, or no additional treatment, following their fire department protocols. Repeat dermal wipes will be collected in all subjects. Core temperature and heart rate will be monitored for up to 8 hours after training scenario. The subjects will collect all their urine after the fire training for a period of 12 hours. The urine will be analyzed for urinary PAH metabolites and potentially other toxicants from the fire, and, dependent on the available budget, similar evaluations may be carried out on the skin wipes.

Interventions

OTHERSauna Rehabilitation

Firefighters selected for sauna rehabilitation will spend time in a sauna

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Working with firefighters during training fire exercises, Dr. Jeff Burgess and his study team will compare a chemical commonly excreted in firefighter urine samples after firefighting to assess the value of adding sauna to rehab post-fire. Firefighter heart rate and temperature will be monitored using a core body temperature/heart rate monitor data recorder. Urine will be collected for 12 hours immediately before the scheduled training fire and for 12 hours afterwards. After the fire, the firefighter will perform the standard rehab. During this time, the University of Arizona (UA) study team will randomly select half of the firefighters to an additional sauna rehab and the other half of the firefighters to no additional rehab. Dermal (skin) wipe samples will be taken off the calf, arm, and neck before the fire, before standard rehab, and after sauna/no additional treatment. A post-fire survey will be administered.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Are employed as an active fire responder by the Fire Department * Are scheduled for a training fire exercise by the Fire Department in the next year * Are currently a non-smoker (including cigarettes, cigars and e-cigarettes) * Cannot have any contraindications to the core temp pill, which are: * weight less than 80 pounds * known or suspected obstructive disease of GI tract, including but not limited to diverticulitis and inflammatory bowel disease * exhibit or have a history of disorders or impairment of the gag reflex * have had a previous gastrointestinal surgery * have any diseases or disorders of the esophagus * will be undergoing Nuclear Magnetic Resonance (NMR) or MRI scanning less than 3 days after swallowing the sensor * have a low motility disorder of the gastrointestinal tract including but not limited to ileus * have a cardiac pacemaker or other implanted electromedical device * have a swallowing disorder

Exclusion criteria

* Are NOT employed as an active fire responder by the Fire Department * Are NOT scheduled for a training fire exercise by the Fire Department in the next year * Are currently a smoker (including cigarettes, cigars and e-cigarettes) * Has one of the contraindications to the core temp pill

Design outcomes

Primary

MeasureTime frameDescription
Urinary Excretion of Hydroxylated PAHs (PAH-OHs)12 hours for urine collectionUrine samples from firefighters post-fire will be measured for hydroxylated PAHs (PAH-OHs) and the concentration compared to pre-fire urine concentrations of PAH-OHs

Countries

United States

Participant flow

Participants by arm

ArmCount
No Additional Rehabilitation
No additional rehabilitation will be done
12
Sauna Rehabilitation
An additional rehabilitation in a sauna will be done Sauna Rehabilitation: Firefighters selected for sauna rehabilitation will spend time in a sauna
12
Total24

Baseline characteristics

CharacteristicNo Additional RehabilitationSauna RehabilitationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
12 Participants12 Participants24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
8 Participants12 Participants20 Participants
Region of Enrollment
United States
12 participants12 participants24 participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants
Sex: Female, Male
Male
11 Participants11 Participants22 Participants
Urinary PAH-OHs10364.2 ng/L
STANDARD_DEVIATION 2.7
6964.1 ng/L
STANDARD_DEVIATION 1.7
8495.7 ng/L
STANDARD_DEVIATION 2.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
0 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

Primary

Urinary Excretion of Hydroxylated PAHs (PAH-OHs)

Urine samples from firefighters post-fire will be measured for hydroxylated PAHs (PAH-OHs) and the concentration compared to pre-fire urine concentrations of PAH-OHs

Time frame: 12 hours for urine collection

ArmMeasureValue (MEAN)Dispersion
Baseline No Additional Rehabilitation Group Urine PAH-OH SumUrinary Excretion of Hydroxylated PAHs (PAH-OHs)10364.2 ng/LStandard Deviation 2.7
Post-fire No Additional Rehabilitation GroupUrinary Excretion of Hydroxylated PAHs (PAH-OHs)40012.1 ng/LStandard Deviation 2.6
Baseline Sauna Rehabilitation Group Urine PAH-OH SumUrinary Excretion of Hydroxylated PAHs (PAH-OHs)6964.1 ng/LStandard Deviation 1.7
Post-fire Sauna Rehabilitation GroupUrinary Excretion of Hydroxylated PAHs (PAH-OHs)22604.3 ng/LStandard Deviation 1.6
p-value: 9e-7t-test, 2 sided
p-value: 0.000018t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026