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临床试验/NCT02659410
NCT02659410Unknown不适用

Studying the Impact of Thermal Stress (Heat) Representative of Occupational Settings on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents

Université de Montréal1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
5
试验地点
1
主要终点
Cardiac frequency

研究概览

简要总结

In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds. Exposure to heat induces physiological responses that help maintaining a stable body temperature. Those changes can affect organ functions implicated in absorption and metabolism. According to literature, those changes could lead to increased concentrations of chemical compounds in the body and their toxicity. Therefore, the aim of this study is to evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress conditions in volunteers exposed in a inhalation chamber. Results will then be used to develop PBPK models that will allow to predict organic solvent kinetics when coexposed with heat.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Body mass index between 18,5 et 25 kg/m3

排除标准

  • •Respiratory, cardiovascular and neurological problems
  • •History of exposure to solvents
  • •Chronic medication
  • •Abusive and/or chronic alcohol consumption
  • •Alcohol consumption 24h before or 18h following exposure

研究组 & 干预措施

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (21) (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (25) (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (30) (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat Stress (21) +TOL (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (25) + TOL (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (21) + TOL (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (21) + ACE (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (25) + ACE (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (21) + TOL (dermal) (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (25) + TOL (dermal) (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (30) + TOL (dermal) (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (30) + ACE (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (21) + DCM (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (25) + DCM (Other)

Heat stress

Experimental

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

干预措施: Heat stress (30) + DCM (Other)

结局指标

主要结局

Cardiac frequency

时间窗: 4hour

Cardiac frequency will be monitored continuously for 4hour with a respirometer

Minute ventilation

时间窗: 4hour

Minute ventilation will be monitored continuously for 4hour with a respirometer

Tidal volume

时间窗: 4hour

Tidal volume will be monitored continuously for 4hour with a respirometer

Solvent in blood

时间窗: 4,5hour

Solvents concentrations will be measured in blood samples collected at different times (t=0, 2, 4 and 4.5hour).

Solvent or metabolite in urine

时间窗: 18hour

Solvent or metabolite concentrations (o-cresol for toluene exposures) will be measured for urine samples collected at different times (t=0, 4, 10 and 18hour).

Solvent in exhaled air

时间窗: 6hour

Solvents concentrations will be measured in exhaled air samples collected at different times (t=0, 1.5, 3, 4.5 and 6hour).

Respiratory rate

时间窗: 4hour

Respiratory rate will be monitored continuously for 4hour with a respirometer

次要结局

  • Oxygen consumption(4hour)
  • Carbonic dioxide production(4hour)
  • Body temperature(4hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sami Haddad

Professor

Université de Montréal

研究点 (1)

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