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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03429348
Recruitment Status : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date  ICMJE February 5, 2018
First Posted Date  ICMJE February 12, 2018
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE April 4, 2018
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
Urinary excretion of PAHs [ Time Frame: 24 hours for urine collection ]
Urine samples from firefighters post-fire will be measured for PAHs and the concentration compared to pre-fire urine concentrations of PAHs
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
Urinary excretion of PAHs [ Time Frame: 24 hours ]
Urine samples from firefighters post-fire will be measured for PAHs and the concentration compared to pre-fire urine concentrations of PAHs
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study
Official Title  ICMJE Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study, IRB# 1801201082
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Working with Scottsdale Fire Department firefighers 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 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.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Post-fire Rehabilitation of Firefighters in Sauna
Intervention  ICMJE Other: Sauna Rehabilitation
Firefighters selected for sauna rehabilitation will spend time in a sauna
Study Arms  ICMJE
  • No Intervention: No additional rehabilitation
    No additional rehabilitation will be done
  • Sauna rehabilitation
    An additional rehabilitation in a sauna will be done
    Intervention: Other: Sauna Rehabilitation
Publications * Crinnion W. Components of practical clinical detox programs--sauna as a therapeutic tool. Altern Ther Health Med. 2007 Mar-Apr;13(2):S154-6. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2018)
40
Estimated Study Completion Date  ICMJE May 31, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are employed as an active fire responder by the Scottsdale Fire Department
  • Are scheduled for a training fire exercise by the Scottsdale 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 Scottsdale Fire Department
  • Are NOT scheduled for a training fire exercise by the Scottsdale 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03429348
Other Study ID Numbers  ICMJE 1801201082
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jefferey L Burgess, MD University of Arizona
PRS Account University of Arizona
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP