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OpenTrials
Completed

NCT Number: NCT05693168

Accuracy of Pulse Oximeter With Profound Hypoxia

Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California, San Francisco

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, between the ages of 18 and 55 years.
  • 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

  • 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 has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation
  • The subject has any other serious systemic illness
  • Th 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

ANNE Limb Sensor

Device

Pulse Oximeter

Primary outcomes

  1. ARMS of SpO2 Measurements with ANNE Limb compared to SaO2

    Time frame: 1 hour

    Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2)

Sponsors and collaborators

Lead sponsor

Sibel Health Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2023
Registry last updated
Jan 20, 2023

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.

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