No registrations found.
ID
Source
Brief title
Health condition
Safety and Tolerability of CO2
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: reaching pre-defined stopping rules pertaining to: significant bloodgas changes (pH, pCO2, pO2), excessive changes in heartrate or bloodpressure, severe side-effects (i.e. headache, nausea, sedation)
Tolerability: time to either subject indicating he wants to discontinue the experiment, or deemed necessary to discontinue the experiment by the investigator/attending physician
Secondary outcome
Cognitive functioning: p-deletion test
Cerebral oxygenation: Invos
Bispectral imaging changes: BIS
Background summary
An observational study looking into the effects of elevated levels of inspired Carbon dioxide in healthy volunteers. With special focus on physiological, behavioral and cognitive paramaters.
Study objective
An observational study looking into the effect of elevated levels of inspired carbon dioxide on physiological, behavioral and cognitive functioning.
Study design
Measurements will take place at 5 or 10 minute interval for: Bloodgas, evaluation of side effects, cognitive tests.
Continuous measurements are collected for:
Cardiac output; Invoss; BIS; levels of inspired gas
Intervention
Escalating exposure duration 10,30 and 60 minutes for the first three concentrations 6%, 7.5% and 9% inspired CO2. Followed by 5 minutes 100% oxygen. For each combination of duration and concentration 6 subjects were included. Escalation af concentration only took place after all durations for this concentration were completed without the occurence of SAE's.
For the concentrations 10% and 12% the maximum duration of exposure was 10 minutes. Followed by 5 minutes 100% oxygen. 10 subjects for the 10% and 10 subjects for the 12% CO2 exposure were included
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
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 wellbeing of the subject, including pulmonary disease such as a history of asthma.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4955 |
| NTR-old | NTR5077 |
| CCMO | NL42820.058.12 |
| OMON | NL-OMON40519 |