Skip to main content
OpenTrials
Completed

NCT Number: NCT03710980

Accuracy of Pulse Oximeters With Profound Hypoxia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Hypoxia Lab

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The subject is obese (BMI>30).
  • The subject has a known history of heart disease, lung disease, kidney or liver disease.
  • Diagnosis of asthma, sleep apnea, or use of CPAP.
  • Subject has diabetes.
  • Subject has a clotting disorder.
  • 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.
  • The subject has any other serious systemic illness.
  • The subject is a current smoker.
  • Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  • The subject has a history of fainting or vasovagal response.
  • The subject has a history of sensitivity to local anesthesia.
  • The subject has a diagnosis of Raynaud's disease.
  • The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • The subject is pregnant, lactating or trying to get pregnant.
  • The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Treatment and study plan

Oximeter

Device

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.

Primary outcomes

  1. SpO2 Accuracy

    Time frame: 60 minutes

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

Sponsors and collaborators

Lead sponsor

Hancock Medical, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2018
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.