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Completed

NCT Number: NCT06460246

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vital Signs Research Group, L.L.C.

San Francisco, California, 94107, United States

About this study

This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. This is done by comparing the pulse oximeter reading during brief, steady state hypoxia plateaus with a gold-standard measurement of blood oxyhaemoglobin saturation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Subject is obese (BMI > 35).
  • 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.
  • Subject has 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.
  • Subject has any other serious systemic illness.
  • 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.
  • Subject has a history of fainting or vasovagal response.
  • Subject has a history of sensitivity to local anesthesia.
  • Subject has a diagnosis of Raynaud's disease.
  • Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • Subject is pregnant, lactating, or trying to get pregnant.
  • Subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • Subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.

Treatment and study plan

Pulse Oximeter

Device

The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters.

Primary outcomes

  1. Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.

    Time frame: 1-4 hours

    Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.

Sponsors and collaborators

Lead sponsor

Acurable Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Aug 23, 2024

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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