CClinicalTrials.gg
Not yet recruitingNCT07503171Updated Mar 31, 2026

Hypoxia and Hemodilution Testing in Healthy Adult Volunteers

An observational study in Hypoxia and Hemodilution, sponsored by Nihon Kohden. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Nihon Kohden · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
7
Ages
18 Years to 35 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hypoxia
  • Hemodilution

Browse trials for

Keywords

  • Pulse oximetry
  • Hb
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 242 are open to participants now.

This study's planned enrollment of 7 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Nihon Kohden is the lead sponsor of 16 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adult volunteers. At least 7 subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
7 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes

Groups and cohorts

  • Adult healthy subjects

    Adult healthy subjects capable of undergoing controlled hypoxemia and hemodilution procedures.

    Device: Noninvasive Physiological Monitoring Device

Interventions

  • DeviceNoninvasive Physiological Monitoring Device

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

06

What researchers measure

Primary outcomes

  1. Collection of Hemoglobin and Oxygen Saturation Measurements

    Collect device readings of oxygen saturation and hemoglobin concentration and reference values obtained from arterial blood samples analyzed using a multi-wavelength laboratory oximeter.

    Time frame: From enrollment to the end of treatment up to 8 hours

07

Study locations

1 site
  • Vital Sign Research Group
    San Francisco, California 94107, United States
08

References and documents

Individual participant data

Plan to share: No — Company confidential

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07503171
Lead sponsor
Nihon Kohden
Responsible party
Sponsor
First posted
Mar 31, 2026
Start date
Apr 2, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Mar 31, 2026

Study contacts

Greg Stratmann, MD, PhD
Contact
stratman@anesthesia.ucsf.edu
(650) 868-5155
Steve Weisner, MS
Contact
steve_weisner@nihonkohden.com
617-318-5904

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion