To determine the effect of SaO2 and PaO2 levels on mitoPO2 and markers of oxygen delivery and consumption in healthy human volunteers.
ID
Source
Brief title
Condition
- Other condition
- Respiratory disorders NEC
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Health condition
Beademing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in mitoPO2 and mitochondrial oxygen consumption at several oxygen
saturations.
Secondary outcome
1. To determine whether ALA-uptake in the skin can be enhanced by using a
dermaroller
2. To determine the effect of hyperoxia and hypoxia on markers of mitochondrial
function and their relation to mitoPO2.
Background summary
The effect of low arterial oxygen saturation on cellular hypoxia remains
unknown. Even though the administration of oxygen is common in the ICU and
perioperative setting, physiological insight into its effect to prevent
cellular hypoxia is lacking. Also, there is concern about toxicity.
Consequently, the optimal oxygen saturation in critically ill patients is still
a matter of controversy. The ability to measure the mitochondrial oxygen
tension non-invasively using the PpIX-technique allows for clinical
investigation into the effect of hypoxia and hyperoxia on mitochondrial
oxygenation and oxygen consumption.
Study objective
To determine the effect of SaO2 and PaO2 levels on mitoPO2 and markers of
oxygen delivery and consumption in healthy human volunteers.
Study design
Physiological human volunteer study
Intervention
Hypoxemia (saturation of 85%) and hyperoxemia (up to FiO2 100%)
Study burden and risks
short episodes of hypoxia and hyperoxia carries minimal to no risk in healthy
individuals. Participants could experience slight physical and psychological
discomfort by placement of the arterial cannula, and temporary loss of mental
focus associated with low oxygen breathing. The measurements will be done in a
time span of 6 hours in a ICU environment. In total 40ml of blood will be drawn
per volunteerpatient, evenly spaced over 5 timepoints. This volume is
negligible compared to total blood volume and not associated with harm.
Participants will not have any personal benefit. Results are likely to benefit
future patients in the ICU or patients needing to undergo surgery.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
Age 18-30 years
healthy participants: absence of active or chronic disease, not taking
medication
BMI 18-25kg/m2
Exclusion criteria
Participation in an investigational drug study within 3 months prior to
screening
Allergy to plaster adhesives
History of photo dermatosis or porphyria
High altitude exposure in previous 3 months >1500m
Active smoking
History of cardiovascular disease
family history of myocardial infarction with age < 50 years
Evidence of conduction abnormalities or previous myocardial ischemia on EKG
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79079.100.22 |