EUCTR2021-003238-35-NO
Active, not recruiting
Phase 1
Effects of supplemental oxygen on systemic and cerebral hemodynamics in experimental hypovolemia: A randomized, phase IV, crossover study to study the effect of supplemental oxygen vs. room air on cerebral and systemic hemodynamics in healthy volunteers > 18 years during experimental hypovolemia in the lower body negative pressure model of hypovolemia. - Supplemental oxygen in hypovolemia
Oslo University Hospital0 sites15 target enrollmentJune 22, 2021
ConditionsHypovolemia is the condition under investigation. Hypovolemia is induced by the lower body negative pressure (LBNP)-model.MedDRA version: 20.0Level: PTClassification code 10049771Term: Shock haemorrhagicSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Body processes [G] - Physiological processes [G07]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypovolemia is the condition under investigation. Hypovolemia is induced by the lower body negative pressure (LBNP)-model.
- Sponsor
- Oslo University Hospital
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \> 18 years.
- •\- Age \< 50 years.
- •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 0
Exclusion Criteria
- •1\.Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted).
- •2\.Pregnancy.
- •3\.Breastfeeding.
- •4\.History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted).
- •5\.Any known cardiac arrhythmia.
- •Prior/Concomitant Therapy
- •6\.Any drug (contraceptives excepted) used on a regular basis for a chronic condition (allergy excepted).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
The effect of oxygen on nausea and vomitingCondition 1: postoperative nausea and vomiting. Condition 2: cataract.Postprocedural disorder of digestive system, unspecifiedcataract,unspecifiedIRCT2016020126300N1Vice Chancellery for Research and Information Technology,Zahedan University of Medical Sciences200
Completed
Phase 3
The effect of supplemental oxygen therapy on the rate of complications after cesarean surgery with Spinal anesthesia method in Besat hospital of SanandajIRCT138806192440N1Affairs Research and Information Management, Kurdistan University of Medical sceinces120
Completed
Phase 1
Supplemental Oxygen in HypovolemiaHypovolemiaHyperoxiaNCT05150418Oslo University Hospital15
Withdrawn
Not Applicable
The effects of oxygen supplementation on oxidative stress biomarkers in the Emergency Department.Patienten met aandoeningen waarvoor zuurstof therapue noodzakelijk is voor of bij binnenkomst op de SEHOxidative stresstoxic effects of oxygenNL-OMON46013Medisch Centrum Leeuwarden100
Withdrawn
Not Applicable
The effect of oxygen supplementation on oxidative stress in the Emergency Department.NL-OMON49342niversitair Medisch Centrum Groningen100