Measuring the effects of CO2 inhalation (6, 8 and 10%) on the body: EEG, heart rate, blood pressure, cardiac output, ECG, oxygen content in the brain, sedation, cognition, nausea.Amendment:Measuring the effects of CO2 inhalation (10% and 12%) on the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
testen van de tolerantie van CO2 inhalatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in EEG, heart rate, blood pressure, cardiac output, ECG, oxygen
content in the brain, sedation, cognition, nausea.
Secondary outcome
-
Background summary
CO2 is a greenhouse gas. To prevent further global warming liquid CO2 is pumped
into the ground. Problems/disasters around these injections can lead to the
release of large amounts of CO2 into the atmosphere. This can lead to
suffocation (due to lack of oxygen) but there are also direct effects of CO2 on
the body. These direct effects are investigated in this study during inhalation
of 6, 8 and 10% CO2 in healthy volunteers.
Amendment:
additonal cohort in which the effects of 10% and 12% CO2 will be investigated
Study objective
Measuring the effects of CO2 inhalation (6, 8 and 10%) on the body: EEG, heart
rate, blood pressure, cardiac output, ECG, oxygen content in the brain,
sedation, cognition, nausea.
Amendment:
Measuring the effects of CO2 inhalation (10% and 12%) on the body: EEG, heart
rate, blood pressure, cardiac output, ECG, oxygen content in the brain,
sedation, cognition, nausea.
Study design
Open and descriptive
Study burden and risks
The burden covers the possible occurrence an nausea / vomiting, headache,
sedation and possibly epileptiform activity. This is a certain amount of load.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Age of 18 to 35 years (inclusive);
2. Body Mass Index (BMI) between 18 and 25 kg/m2 (inclusive) and body weight between 50 kg and 100 kg (inclusive);
3. Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
Exclusion criteria
1. Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator);
2. A semi recumbent systolic blood pressure of >150 mmHg and/or diastolic blood pressure of > 90 mmHg at screening;
3. History of alcoholism or substance abuse within three years prior to screening;
4. Use of medication during the study period;
5. Subjects smoking > 10 cigarettes/day or equivalents
6. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year;
7. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject, including pulmonary disease such as a history of asthma.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42820.058.12 |
| OMON | NL-OMON22471 |