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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
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Nihon Kohden

Brief Summary:
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest

Condition or disease Intervention/treatment
Hypoxia Device: Pulse oximeter

Detailed Description:
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

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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
Device: Pulse oximeter
OLV-4202 pulse oximeter (SW version: 01-12)




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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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
Study Population
Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.
Criteria

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

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): NCT05297500


Locations
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United States, California
UCSF Hypoxia Research Laboratory
San Francisco, California, United States, 94133
Sponsors and Collaborators
Nihon Kohden
University of California, San Francisco
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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

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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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory