Healthy Volunteers
Conditions
Brief summary
Prospective, controlled, randomized crossover volunteer study to investigate the effect of hyperoxemia due to inhalation of oxygen (80% inspiratory fraction) via reservoir-face-mask on blood coagulation, especially platelet function, as measured by thrombelastography. According to results of basic animal and in vitro investigations, hyperoxemia may activate platelets by means of reactive oxygen species. This study aims at investigating a possible pro-coagulant effect of hyperoxemia in healthy volunteers. Additional studies on possible mechanisms are integrated. * Trial with medical device
Interventions
Inhalation of 80% oxygen via face mask
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* informed consent; no coagulation disorder or other illnesses; * non-smoker; * women: no pharmacological contraception, negative pregnancy test; * 25-45 years old; no medication; no acute or chronic airway problems; * for 24 hours before study: no extreme physical activity, no polyphenol-containing food (red wine, apples, cabbage, garlic); * for 48 hours: no caffeine-containing drinks, no dark chocolate.
Exclusion criteria
* Lack of one of the inclusion criteria; * allergy or incompatibility to substances/materials applied in the study; * very thin veins/arteries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum amplitude in thrombelastography | 1 hour |
Countries
Switzerland
Outcome results
None listed