Nitrous Oxide PoisoningNCT04050267
Effects of Low Concentrations of Nitrous Oxide
A study testing Nitrous Oxide in people with Nitrous Oxide Poisoning, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
The aim of the study is to test the effects of low concentrations of nitrous oxide on cognitive functions and reaction time in human. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nitrous Oxide Poisoning
- What is being tested?
- Nitrous Oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Apr 2019to 29 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers from the Czech Technical University
Who cannot join
- pregnancy
- allergy to nitrous oxide
- severe asthma or other severe respiratory conditions
- severe cardiovascular conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low Concentrations of Nitrous Oxide on Cognitive Functions and Reaction Time
The aim of the study is to test the effects of low concentrations of nitrous oxide on cognitive functions and reaction time in human.
Read the detailed description
Nitrous oxide is a widely used gas in medicine, in standard concentrations above 50%. Its favourable physical properties and easy detectability by anaesthetic gas analysors predispose nitrous oxide to become a possible "tracing gas" for leak detection in experiments in which modified breathing system are in use. In these breathing experiments, the inspired concentrations of nitrous oxide would be well below the anaesthetic/analgesic concentrations. The aim of this study is to investigate the effects of these low concentrations of nitrous oxide (5, 7, 10, 12, 15, 20 %), compared to placebo (air, 0% nitrous oxide). The cognitive functions are tested using Digit Symbol Substitution Test, Reaction Time and Visual Analogue Scale.
- Conditions
- Nitrous Oxide Poisoning
- Being tested
- Nitrous Oxide, Placebo - air
- Keywords
- nitrous oxide, tracing gas, breathing experiments, cognitive tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.
Placebo - airOther
Breathing air with 21 % oxygen, no nitrous oxide.
| Study group | Role | What they receive |
|---|---|---|
| Control group - air | Placebo comparator | Breathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol. Receives: Other: Placebo - air |
| Intervention Group - 5% nitrous oxide | Experimental | Breathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. Receives: Drug: Nitrous Oxide |
| Intervention Group - 7% nitrous oxide | Experimental | Breathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. Receives: Drug: Nitrous Oxide |
| Intervention Group - 10% nitrous oxide | Experimental | Breathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. Receives: Drug: Nitrous Oxide |
| Intervention Group - 12% nitrous oxide | Experimental | Breathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. Receives: Drug: Nitrous Oxide |
| Intervention Group - 15% nitrous oxide | Experimental | Breathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. Receives: Drug: Nitrous Oxide |
| Intervention Group - 20% nitrous oxide | Experimental | Breathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. Receives: Drug: Nitrous Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive test results
The results of cognitive test performed during inhalation of defined concentration of nitrous oxide. Cognitive tests: Digit Symbol Substitution Test (DSST).
Measured: Through study completion, an average of 1 year
Reaction Time
The results of reaction time test performed during inhalation of defined concentration of nitrous oxide. Reaction Time (in seconds) using a computer-based test.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start25 Apr 2019
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitrous Oxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants go through all study arms, in random order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, prof., Ph.D., Study director, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050267
- Sponsor's protocol ID
- VentRes-2019-02-KR
- Status last verified
- Aug 2019
- First submitted
- 15 May 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Concentrations of Nitrous Oxide on Cognitive Functions and Reaction Time
- ClinicalTrials.gov ID
- NCT04050267
- Acronym / sponsor ID
- VentRes-2019-02-KR
- Conditions
- Nitrous Oxide Poisoning
- Keywords
- nitrous oxide, tracing gas, breathing experiments, cognitive tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to test the effects of low concentrations of nitrous oxide on cognitive functions and reaction time in human.
Detailed description
Nitrous oxide is a widely used gas in medicine, in standard concentrations above 50%. Its favourable physical properties and easy detectability by anaesthetic gas analysors predispose nitrous oxide to become a possible "tracing gas" for leak detection in experiments in which modified breathing system are in use. In these breathing experiments, the inspired concentrations of nitrous oxide would be well below the anaesthetic/analgesic concentrations. The aim of this study is to investigate the effects of these low concentrations of nitrous oxide (5, 7, 10, 12, 15, 20 %), compared to placebo (air, 0% nitrous oxide). The cognitive functions are tested using Digit Symbol Substitution Test, Reaction Time and Visual Analogue Scale.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
- Model description
- All participants go through all study arms, in random order.
| Arm | Type | Receives |
|---|---|---|
| Control group - air | Placebo comparator | Other: Placebo - airBreathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol. |
| Intervention Group - 5% nitrous oxide | Experimental | Drug: Nitrous OxideBreathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
| Intervention Group - 7% nitrous oxide | Experimental | Drug: Nitrous OxideBreathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
| Intervention Group - 10% nitrous oxide | Experimental | Drug: Nitrous OxideBreathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
| Intervention Group - 12% nitrous oxide | Experimental | Drug: Nitrous OxideBreathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
| Intervention Group - 15% nitrous oxide | Experimental | Drug: Nitrous OxideBreathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
| Intervention Group - 20% nitrous oxide | Experimental | Drug: Nitrous OxideBreathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers from the Czech Technical University
Key exclusion criteria (4 listed)
- pregnancy
- allergy to nitrous oxide
- severe asthma or other severe respiratory conditions
- severe cardiovascular conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous OxideBreathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order. | Drug | Intervention Group - 10% nitrous oxide, Intervention Group - 12% nitrous oxide, Intervention Group - 15% nitrous oxide, Intervention Group - 20% nitrous oxide, Intervention Group - 5% nitrous oxide, Intervention Group - 7% nitrous oxide |
| Placebo - airBreathing air with 21 % oxygen, no nitrous oxide. | Other | Control group - air |
Primary outcome
Cognitive test results
Time frame: Through study completion, an average of 1 year
The results of cognitive test performed during inhalation of defined concentration of nitrous oxide. Cognitive tests: Digit Symbol Substitution Test (DSST).
Reaction Time
Time frame: Through study completion, an average of 1 year
The results of reaction time test performed during inhalation of defined concentration of nitrous oxide. Reaction Time (in seconds) using a computer-based test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Roubik, prof., Ph.D. study director
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrous Oxide in people with Nitrous Oxide Poisoning, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive test results (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.