Undersøgelse af Lattergaskoncentrationer i Blod, udåndingsluft og Urin Ved Forskellige Eksponeringer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Detection time of Nitrous Oxide in blood
研究概览
简要总结
The study examines the concentrations of nitrous oxide that are achieved in blood, exhaled air, and urine after three different exposures to nitrous oxide:
inhalation of three or four cartridges of nitrous oxide released in a car cabin in a switched-off car, consumption of 100 g of whipped cream in which nitrous oxide is used as a propellant, and exposure through work as a midwife in a delivery room.
The concentrations in blood and exhaled air are measured for up to 1 hour after exposure, and in urine for up to 2 hours after exposure. The concentrations in blood and urine are measued with gas chromatography and mass spectrometry, while the concentration in exhaled air is measured by a sensor using an NDIR sensor (Olythe, France).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For arm 1, 2, and 3:
- •Inclusion Criteria:
- •Age 18-65 years
- •Able to understand Danish
- •Willing to use effective contraception for 24 hours after the end of exposure (oral contraceptives, contraceptive implant, transdermal patch, vaginal ring, or injectable contraceptives)
- •Written informed consent
排除标准
- •Current or past abuse of drugs, nitrous oxide (N₂O), or alcohol
- •A psychiatric disorder requiring medical treatment, including severe depression
- •A diagnosis of epilepsy
- •Symptoms of peripheral neuropathy
- •Significant cardiac or pulmonary disease
- •Previous allergic or adverse reaction to N₂O
- •Diving within the past 2 days
- •Inability to refrain from diving for 2 days after the study
- •Occupational exposure to N₂O
- •Use of N₂O within the past 3 months
- •Treatment with methotrexate, benzodiazepines, opioids, or other centrally depressant drugs
- •Recent intraocular gas injection
- •Known impaired liver or kidney function
- •Pregnant or breastfeeding women (fertile women, defined as amenorrhea for less than 12 months, must have a negative hCG pregnancy test prior to receiving the study intervention)
结局指标
主要结局
Detection time of Nitrous Oxide in blood
时间窗: From end of exposure to 1 hour after end of exposure
The time after exposure in which Nitrous Oxide can be detected in blood
次要结局
未报告次要终点