Response of the heart and blood vessels on different concentrations of oxyge
Phase 1
- Conditions
- Healthy cardiovascular systemTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2016-002342-23-NL
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy
18-55 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Active smoking
- Diagnosed lung pathology (which requires medication or impedes exercise)
- Diagnosed left-right shunt
- Diagnosed cardiovascular disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To explore the dose-response relationship between PaO2 and sublingual microcirculatory perfusion.;Secondary Objective: To explore the dose-response relationship between PaO2 and systemic hemodynamics;Primary end point(s): The main study parameter is the change in perfused vessel density (PVD) of small vessels (<20 µm), as measured by sublingual sidestream darkfield imaging;Timepoint(s) of evaluation of this end point: After 10 minutes of supplemental oxygen breathing
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Cardiac Output<br>- Systemic Vascular Resistance<br>- Heart Rate<br>- Mean Arterial Pressure<br>;Timepoint(s) of evaluation of this end point: After 10 minutes of supplemental oxygen breathing