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Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia

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ClinicalTrials.gov Identifier: NCT04380389
Recruitment Status : Completed
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Withings

Brief Summary:
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.

Condition or disease Intervention/treatment Phase
Oximetry Diagnostic Test: hypoxia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Actual Study Start Date : March 11, 2020
Actual Primary Completion Date : March 12, 2020
Actual Study Completion Date : March 12, 2020

Arm Intervention/treatment
profound hypoxia Diagnostic Test: hypoxia
Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.




Primary Outcome Measures :
  1. RMSE compared to CO-oximetry [ Time Frame: 1 hour ]
    Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 has both wrist circumferences between 14 and 22cm.
  • 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 blood sample 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.
  • The subject has piercings that may cause air leaks during the test
  • The subject has 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 a resting heartrate over 120, Systolic BP is over 150, diastolic BP is over 90 or room air SpO2 is less than 94%.
  • The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis.
  • The subject has any other condition, which in the opinion of the investigators' would make them unsuitable to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380389


Locations
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United States, California
Hypoxia Lab, UCSF
San Francisco, California, United States, 94133
Sponsors and Collaborators
Withings
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Withings
ClinicalTrials.gov Identifier: NCT04380389    
Other Study ID Numbers: pulse ox
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory