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Effects of Low Concentrations of Nitrous Oxide

Primary Purpose

Nitrous Oxide Poisoning

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Nitrous Oxide

Placebo - air

About this trial

This is an interventional basic science trial for Nitrous Oxide Poisoning focused on measuring nitrous oxide, tracing gas, breathing experiments, cognitive tests

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

healthy volunteers from the Czech Technical University

Exclusion Criteria:

pregnancy
allergy to nitrous oxide
severe asthma or other severe respiratory conditions
severe cardiovascular conditions

Sites / Locations

Czech Technical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group - air

Intervention Group - 5% nitrous oxide

Intervention Group - 7% nitrous oxide

Intervention Group - 10% nitrous oxide

Intervention Group - 12% nitrous oxide

Intervention Group - 15% nitrous oxide

Intervention Group - 20% nitrous oxide

Arm Description

Breathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol.

Breathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Breathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Breathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Breathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Breathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Breathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Outcomes

Primary Outcome Measures

Cognitive test results

The results of cognitive test performed during inhalation of defined concentration of nitrous oxide. Cognitive tests: Digit Symbol Substitution Test (DSST).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04050267

First Posted

May 15, 2019

Last Updated

August 7, 2019

Sponsor

Czech Technical University in Prague

1. Study Identification

Unique Protocol Identification Number

NCT04050267

Brief Title

Effects of Low Concentrations of Nitrous Oxide

Official Title

Effects of Low Concentrations of Nitrous Oxide on Cognitive Functions and Reaction Time

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

April 25, 2019 (Actual)

Primary Completion Date

April 29, 2019 (Actual)

Study Completion Date

April 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Czech Technical University in Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nitrous Oxide Poisoning

Keywords

nitrous oxide, tracing gas, breathing experiments, cognitive tests

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

All participants go through all study arms, in random order.

Masking

Participant

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group - air

Arm Type

Placebo Comparator

Arm Description

Breathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol.

Arm Title

Intervention Group - 5% nitrous oxide

Arm Type

Experimental

Arm Description

Breathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Arm Title

Intervention Group - 7% nitrous oxide

Arm Type

Experimental

Arm Description

Breathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Arm Title

Intervention Group - 10% nitrous oxide

Arm Type

Experimental

Arm Description

Breathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Arm Title

Intervention Group - 12% nitrous oxide

Arm Type

Experimental

Arm Description

Breathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Arm Title

Intervention Group - 15% nitrous oxide

Arm Type

Experimental

Arm Description

Breathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Arm Title

Intervention Group - 20% nitrous oxide

Arm Type

Experimental

Arm Description

Breathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Intervention Type

Drug

Intervention Name(s)

Nitrous Oxide

Intervention Description

Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.

Intervention Type

Other

Intervention Name(s)

Placebo - air

Intervention Description

Breathing air with 21 % oxygen, no nitrous oxide.

Primary Outcome Measure Information:

Title

Cognitive test results

Description

The results of cognitive test performed during inhalation of defined concentration of nitrous oxide. Cognitive tests: Digit Symbol Substitution Test (DSST).

Time Frame

Through study completion, an average of 1 year

Title

Reaction Time

Description

The results of reaction time test performed during inhalation of defined concentration of nitrous oxide. Reaction Time (in seconds) using a computer-based test.

Time Frame

Through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: healthy volunteers from the Czech Technical University Exclusion Criteria: pregnancy allergy to nitrous oxide severe asthma or other severe respiratory conditions severe cardiovascular conditions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karel Roubik, prof., Ph.D.

Organizational Affiliation

Czech Technical University in Prague

Official's Role

Study Director

Facility Information:

Facility Name

Czech Technical University

City

Praha

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Low Concentrations of Nitrous Oxide

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