Concentrations of Nitrous Oxide in Blood, Exhaled Air and Urine After Various Types of Exposure.
Undersøgelse af Lattergaskoncentrationer i Blod, udåndingsluft og Urin Ved Forskellige Eksponeringer
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).
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Charlotte U Andersen, Associate Professor
- 电话号码:+4560128430
- 邮箱:cua@biomed.au.dk
学习地点
-
-
-
Aarhus、丹麦、8200
- 招聘中
- Department of Forensic Medicine
-
接触:
- Charlotte U Andersen, Associate Professor
- 电话号码:+4560128430
- 邮箱:cua@biomed.au.dk
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Passive exposure in car, 3 cartridges
A person sits for 15 minutes after releasing 4 x 8.4 g of nitrous oxide into the cabin
|
Passive exposure to Nitrous Oxide
|
|
实验性的:Passive exposure in car, 4 cartridges
A person sits for 15 minutes after releasing 4 x 8.4 g of nitrous oxide into the cabin
|
Passive exposure to Nitrous Oxide
|
|
实验性的:Whipped cream, 100 g
A person ingests 100 g of whipped cream with nitrous oxide as propellant
|
Passive exposure to Nitrous Oxide
|
|
有源比较器:Environmental exposure
concentrations of nitrous oxide are measured after exposure through work as a midwife in a delivery room
|
Midwifes are exposed through work in a delivery room
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Detection time of Nitrous Oxide in blood
大体时间:From end of exposure to 1 hour after end of exposure
|
The time after exposure in which Nitrous Oxide can be detected in blood
|
From end of exposure to 1 hour after end of exposure
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.