Supplemental Oxygen in Hypovolemia

NCT05150418 | Completed Phase 1

• 1 other identifier: 1_08-06-2021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypovolemia; Hyperoxia

Outcome Measures

Primary Outcomes (1)

• Cardiac output

  Cardiac output (stroke volume \* heart rate)

  Through LBNP exposure completion, up to 35 minutes

Secondary Outcomes (3)

• Cardiac stroke volume

  Through LBNP exposure completion, up to 35 minutes

• Middle cerebral artery blood flow velocity (MCAV)

  Through LBNP exposure completion, up to 35 minutes

• Time to decompensation

  Through LBNP exposure completion, up to 35 minutes

Study Arms (2)

Oxygen

EXPERIMENTAL

Oxygen 15 l/min administered with face mask with reservoir.

Drug: Oxygen gas

Room air

PLACEBO COMPARATOR

Room air 15 l/min administered with face mask with reservoir.

Drug: Air

Interventions

Oxygen gas DRUG

Oxygen 15 l/min

Oxygen

Air DRUG

Room air 15 l/min

Room air

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Age
• Participant must be 18 years of age inclusive, at the time of signing the informed consent.
• Participant must be under 50 years of age inclusive, at the time of signing the informed consent.
• Type of Participant and Disease Characteristics
• 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
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male participants: Not applicable.
• 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.
• 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.
• 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

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions
• Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted).
• Pregnancy.
• Breastfeeding.
• History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted).
• Any known cardiac arrhythmia. Prior/Concomitant Therapy
• Any drug (contraceptives excepted) used on a regular basis for a chronic condition (allergy excepted).

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Air Ambulance Foundation: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0586, Norway

Location

Related Publications (1)

• Lie SL, Hisdal J, Rehn M, Hoiseth LO. Hemodynamic effects of supplemental oxygen versus air in simulated blood loss in healthy volunteers: a randomized, controlled, double-blind, crossover trial. Intensive Care Med Exp. 2023 Nov 10;11(1):76. doi: 10.1186/s40635-023-00561-z.

  PMID: 37947905 DERIVED

MeSH Terms

Conditions

Hypovolemia; Hyperoxia

Interventions

nitrox; Air

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Oxygen or room air administered.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, randomized, crossover design.

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 9, 2021
• Study Start: November 26, 2021
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)