Hypoxia and Hemodilution Testing in Healthy Adult Volunteers

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-35
SponsorNihon Kohden

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

In good general health with no evidence of significant medical problems.

Fluent in both written and spoken English.

Disqualifiers

BMI above 30.

History of heart, lung, kidney, or liver disease.

Diagnosis of asthma, sleep apnea, or use of CPAP.

Diabetes mellitus.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Noninvasive Physiological Monitoring Device

    Device

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

Treatment groups

7 Participants
are divided into 1 treatment group
Group A: Adult healthy subjects1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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