Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03429348
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2018-02-05
Brief Title:
Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study Institutional Review Board 1801201082
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None