- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07690358
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Charlotte U Andersen, Associate Professor
- Phone Number: +4560128430
- Email: cua@biomed.au.dk
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Recruiting
- Department of Forensic Medicine
-
Contact:
- Charlotte U Andersen, Associate Professor
- Phone Number: +4560128430
- Email: cua@biomed.au.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: Whipped cream, 100 g
A person ingests 100 g of whipped cream with nitrous oxide as propellant
|
Passive exposure to Nitrous Oxide
|
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection time of Nitrous Oxide in blood
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-10-72-156-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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