Supplemental Oxygen in Hypovolemia

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Supplemental oxygen is frequently administered in acutely and critically ill patients, specifically, it is often administered in trauma patients to avoid arterial hypoxemia and tissue hypoxia. There is also an increasing focus on potentially deleterious effects of hyperoxia. Further, the hemodynamic response to hyperoxia in hypovolemia is poorly understood.

The present study aims to investigate the effects of supplemental oxygen on systemic and cerebral hemodynamics in simulated hypovolemia in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: Norwegian Air Ambulance Foundation

Criteria

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Age

1. Participant must be 18 years of age inclusive, at the time of signing the informed consent.

2. Participant must be under 50 years of age inclusive, at the time of signing the informed consent.

Type of Participant and Disease Characteristics

3. Participants who are overtly healthy as determined by medical evaluation including medical history, heart and lung auscultation, focused cardiac ultrasound and measurement of cardiac conduction times.

Sex and Contraceptive/Barrier Requirements

4. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

1. Male participants: Not applicable.

2. Female participants:

Use of adequate birth control for women of childbearing potential.

• A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile when sexually active. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

• Inclusion of WOCBP is possible when either:

• Using at least an acceptable effective contraceptive measure (combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence). As a minimum contraception should be maintained until treatment discontinuation.

or

• Confirmed negative highly sensitive urine or serum pregnancy test at screening. A pregnancy test is performed at any visit before administering IMP if more than 14 days have passed since last pregnancy test. There will be no demand for post-intervention contraception.

Informed Consent

5. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions

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).