Hypoxia and Hemodilution Testing in Healthy Adult Volunteers

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07503171

Enrollment

Registered

2026-03-31

Start date

2026-04-02

Completion date

2028-01-31

Last updated

2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodilution, Hypoxia

Keywords

Pulse oximetry, Hb

Brief summary

This study will collect physiological measurements in healthy adult volunteers under controlled hypoxia and hemodilution conditions.

Detailed description

Subjects will undergo stepwise reductions in oxygen saturation and hemoglobin concentration while noninvasive monitoring data are recorded and compared with reference blood measurements.

Interventions

DEVICENoninvasive Physiological Monitoring Device

Octopal R Noninvasive Pulse Wave Measuring Device DMO-8000X with TL 811S Finger Probe

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

1. In good general health with no evidence of significant medical problems. 2. Fluent in both written and spoken English. 4\. Has provided written informed consent and is willing to comply with study procedures.

Exclusion criteria

1. BMI above 30. 2. History of heart, lung, kidney, or liver disease. 3. Diagnosis of asthma, sleep apnea, or use of CPAP. 4. Diabetes mellitus. 5. Clotting disorders. 6. Hemoglobinopathy or history of anemia (ctHb \<12 g/dL for men, \<11 g/dL for women, COHb \>2%). 7. Any serious systemic illness. 8. Current smoker. 9. Injury or abnormality at sensor sites interfering with measurements. 10. History of fainting or vasovagal response. 11. Sensitivity to local anesthesia. 12. Diagnosis of Raynaud's disease. 13. Unacceptable collateral circulation (Allen's test). 14. Pregnant, lactating, or attempting to become pregnant. 15. Unable or unwilling to provide informed consent or comply with study procedures. 16. Any other condition deemed unsuitable by the investigator.

Design outcomes

Primary

Measure	Time frame	Description
Collection of Hemoglobin and Oxygen Saturation Measurements	From enrollment to the end of treatment up to 8 hours	Collect device readings of oxygen saturation and hemoglobin concentration and reference values obtained from arterial blood samples analyzed using a multi-wavelength laboratory oximeter.

Countries

United States

Contacts

CONTACTGreg Stratmann, MD, PhD

stratman@anesthesia.ucsf.edu(650) 868-5155

CONTACTSteve Weisner, MS

steve_weisner@nihonkohden.com617-318-5904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026