Hypoxia and Hemodilution Testing in Healthy Adult Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Noninvasive Physiological Monitoring Device.
- Who it may be relevant to
- Registry conditions: Hypoxia, Hemodilution. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Noninvasive Physiological Monitoring Device
Octopal R Noninvasive Pulse Wave Measuring Device DMO-8000X with TL 811S Finger Probe
Primary outcome measures
- Collection of Hemoglobin and Oxygen Saturation Measurements [Time frame: From enrollment to the end of treatment up to 8 hours]
Eligibility criteria
Inclusion criteria
- In good general health with no evidence of significant medical problems.
- Fluent in both written and spoken English.
4\. Has provided written informed consent and is willing to comply with study procedures.
Exclusion criteria
- BMI above 30.
- History of heart, lung, kidney, or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Diabetes mellitus.
- Clotting disorders.
- Hemoglobinopathy or history of anemia (ctHb <12 g/dL for men, <11 g/dL for women, COHb >2%).
- Any serious systemic illness.
- Current smoker.
- Injury or abnormality at sensor sites interfering with measurements.
- History of fainting or vasovagal response.
- Sensitivity to local anesthesia.
- Diagnosis of Raynaud's disease.
- Unacceptable collateral circulation (Allen's test).
- Pregnant, lactating, or attempting to become pregnant.
- Unable or unwilling to provide informed consent or comply with study procedures.
- Any other condition deemed unsuitable by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Vital Sign Research Group — San Francisco
Identifiers
NCT: NCT07503171 · 75Ag-00043