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Tolerability and physiological effects of elevated inspired carbon dioxide (CO2) concentrations in human volunteers


- candidate number21367
- NTR NumberNTR5077
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2015
- Secondary IDsNL42820.058.12;P12.281 CCMO;CME
- Public TitleTolerability and physiological effects of elevated inspired carbon dioxide (CO2) concentrations in human volunteers
- Scientific TitleTolerability and physiological effects of elevated inspired carbon dioxide (CO2) concentrations in human volunteers
- ACRONYMTOPofCO2
- hypothesisAn observational study looking into the effect of elevated levels of inspired carbon dioxide on physiological, behavioral and cognitive functioning.
- Healt Condition(s) or Problem(s) studiedSafety, Tolerability, CO2
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 20-jun-2013
- planned closingdate1-jun-2015
- Target number of participants74
- InterventionsEscalating 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
- Primary outcomeSafety: 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 outcomeCognitive functioning: p-deletion test
Cerebral oxygenation: Invos
Bispectral imaging changes: BIS

- TimepointsMeasurements 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
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
CATO-2: financial support
- PublicationsNA
- Brief summaryAn 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.
- Main changes (audit trail)
- RECORD8-jan-2015 - 25-apr-2015


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