Back to resultsAccuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Primary Purpose
Oximetry
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hypoxia
Sponsored by
About this trial
This is an interventional diagnostic trial for Oximetry
Eligibility 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.
Sites / Locations
- Hypoxia Lab, UCSF
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
profound hypoxia
Arm Description
Outcomes
Primary Outcome Measures
RMSE compared to CO-oximetry
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04380389
Brief Title
Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Official Title
Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Withings
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oximetry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
profound hypoxia
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
hypoxia
Intervention Description
Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.
Primary Outcome Measure Information:
Title
RMSE compared to CO-oximetry
Description
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.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Hypoxia Lab, UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33857011
Citation
Kirszenblat R, Edouard P. Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study. J Med Internet Res. 2021 Apr 26;23(4):e27503. doi: 10.2196/27503.
Results Reference
derived
Links:
URL
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-drug
Description
Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff, March 4, 2013
URL
https://www.iso.org/fr/standard/67963.html
Description
ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Learn more about this trial
Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
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