Tolerability and physiological effects of elevated inspired carbon dioxide (CO2) concentrations in human volunteers
- Conditions
- testen van de tolerantie van CO2 inhalatiePhysiological effect of carbon dioxide
- Registration Number
- NL-OMON40519
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 74
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;
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Changes in EEG, heart rate, blood pressure, cardiac output, ECG, oxygen<br /><br>content in the brain, sedation, cognition, nausea.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-</p><br>