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CompletedNCT03710980Updated Oct 18, 2018

Accuracy of Pulse Oximeters With Profound Hypoxia

An observational study in Oximetry, sponsored by Hancock Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-18.

Sponsored by Hancock Medical, Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.

02

Conditions studied

  • Oximetry

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 12 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Hancock Medical, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy adult volunteers.

Inclusion criteria

  1. The subject is male or female, aged ≥18 and \<50.
  2. The subject is in good general health with no evidence of any medical problems.
  3. The subject is fluent in both written and spoken English.
  4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion criteria

Exclusion Criteria:

  1. The subject is obese (BMI>30).
  2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
  3. Diagnosis of asthma, sleep apnea, or use of CPAP.
  4. Subject has diabetes.
  5. Subject has a clotting disorder.
  6. The subject a hemoglobinopathy or history of anemia, per subject report or the first bloodsample, that in the opinion of the investigator, would make them unsuitable for study participation.
  7. The subject has any other serious systemic illness.
  8. The subject is a current smoker.
  9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  10. The subject has a history of fainting or vasovagal response.
  11. The subject has a history of sensitivity to local anesthesia.
  12. The subject has a diagnosis of Raynaud's disease.
  13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  14. The subject is pregnant, lactating or trying to get pregnant.
  15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy Adult Volunteer

    Device: Oximeter

Interventions

  • DeviceOximeter

    Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding arterial blood draw samples to assess oximeter accuracy.

06

What researchers measure

Primary outcomes

  1. SpO2 Accuracy

    Collect and analyze data to determine SpO2 accuracy of oximeters under test.

    Time frame: 60 minutes

07

Study locations

1 site
  • UCSF Hypoxia Lab
    San Francisco, California 94143, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03710980
Lead sponsor
Hancock Medical, Inc.
Responsible party
Sponsor
First posted
Oct 18, 2018
Start date
Sep 18, 2018
Primary completion
Sep 19, 2018
Completion
Sep 19, 2018
Last update
Oct 18, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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