Determination of SpO2 and PR Accuracy Specifications at Rest
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ClinicalTrials.gov Identifier: NCT05297500 |
Recruitment Status :
Active, not recruiting
First Posted : March 28, 2022
Last Update Posted : April 22, 2022
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Condition or disease | Intervention/treatment |
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Hypoxia | Device: Pulse oximeter |
Study Type : | Observational |
Actual Enrollment : | 12 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 14 |
Actual Study Start Date : | March 23, 2022 |
Actual Primary Completion Date : | March 28, 2022 |
Estimated Study Completion Date : | March 29, 2023 |
Group/Cohort | Intervention/treatment |
---|---|
Adult healthy subjects
Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state
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Device: Pulse oximeter
OLV-4202 pulse oximeter (SW version: 01-12) |
- Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%) [ Time Frame: 30 minutes ]
Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.
Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:
room air, 92%, 87%, 82%, 77%, 72%
Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:
100%, 93%, 88%, 83%, 78%, 73%
SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value.
- Root-mean-square (Rms) of device Pulse Rate measurement with room air stabilization is within +-3 [1/min] of reference ECG Pulse Rate measurement at heart rates (30 to 300 [1/min]) [ Time Frame: 30 minutes ]
Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.
Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:
room air, 92%, 87%, 82%, 77%, 72%
Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:
100%, 93%, 88%, 83%, 78%, 73%
Pulse rate is recorded from the test device and from the reference ECG monitor. PR data measurements are gathered during the stable plateau value at the desired saturation target. Each desaturation plateaus should not exceed 10 minutes. The gas mixture is then changed for the next value and repeated for each plateau value.
- Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at desaturation levels (80% to 100%) and within +-3% [%SpO2] at desaturation levels (70% to 80%) [ Time Frame: 30 minutes ]
Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.
Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:
room air, 92%, 87%, 82%, 77%, 72%
Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:
100%, 93%, 88%, 83%, 78%, 73%
SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Both male and female subjects who can give written informed consent
- Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
- Meeting the demographic requirements
Exclusion Criteria:
- Pregnant women
- Significant arrhythmia
- Blood pressure above 150 systolic or 90 diastolic
- Carboxyhemoglobin levels over 3%
- Subjects whom the investigator consider ineligible for the study

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): NCT05297500
United States, California | |
UCSF Hypoxia Research Laboratory | |
San Francisco, California, United States, 94133 |
Responsible Party: | Nihon Kohden |
ClinicalTrials.gov Identifier: | NCT05297500 |
Other Study ID Numbers: |
71Ag_Vital-0031 |
First Posted: | March 28, 2022 Key Record Dates |
Last Update Posted: | April 22, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data to be used by Sponsor only |
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 |
Product Manufactured in and Exported from the U.S.: | No |
Hypoxia Signs and Symptoms, Respiratory |