Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Accuracy of Pulse Oximeters With Profound Hypoxia During Motion (NIHO12)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04814342
Recruitment Status : Enrolling by invitation
First Posted : March 24, 2021
Last Update Posted : March 30, 2021
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 during controlled motion.

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 during controlled motion.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of SpO2 and PR Accuracy Specifications During Motion Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : March 22, 2022
Estimated Study Completion Date : March 21, 2023

Intervention Details:
  • Device: Pulse oximeter
    OLV-4202 pulse oximeter (SW version: 01-11)


Primary Outcome Measures :
  1. Deviation of device SpO2 measurement during motion with room air stabilization from control stationary SpO2 measurement at varying desaturation levels (Run 1) [ Time Frame: 30 minutes ]

    Each subject will have pulse oximeter study device placed on different fingers of the left/right hand, or the left/right earlobe or the forehead. Motion is varied randomly by rubbing or tapping. The control stationary measurements will be on the same patient opposite hand in varying fingers. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.

    Run 1 starts with a stabilized period at room air and is followed by stabilized plateaus at various lower saturation level targets:

    room air, 90 percent, 80 percent, 70 percent

    SpO2 is observed breath by breath arterial saturation computed from end tidal PO2 and PCO2. FiO2 is reduced 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. Deviation of device SpO2 measurement during motion with 100 percent oxygen stabilization from control stationary SpO2 measurement at varying desaturation levels (Run 2) [ Time Frame: 30 minutes ]

    Each subject will have pulse oximeter study device placed on different fingers of the left/right hand, or the left/right earlobe or the forehead. Motion is varied randomly by rubbing or tapping. The control stationary measurements will be on the same patient opposite hand in varying fingers. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.

    Run 2 starts with a stabilized period at 100 percent oxygen and is followed by stabilized plateaus at various lower saturation level targets:

    100 percent, 95 percent, 85 percent, 75 percent

    SpO2 is observed breath by breath arterial saturation computed from end tidal PO2 and PCO2. FiO2 is reduced 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.



Secondary Outcome Measures :
  1. Deviation of device PR measurement with room air stabilization from commercial ECG monitor HR at varying desaturation levels (Run 1) [ Time Frame: 30 minutes ]

    Each subject will have ECG electrodes from a commercial ECG monitor 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. Motion is varied randomly by rubbing or tapping. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.

    Run 1 starts with a stabilized period at room air and is followed by stabilized plateaus at various lower saturation level targets:

    room air, 90 percent, 80 percent, 70 percent

    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.


  2. Deviation of device PR measurement with 100 percent oxygen stabilization from commercial ECG monitor HR at varying desaturation levels (Run 2) [ Time Frame: 30 minutes ]

    Each subject will have ECG electrodes from a commercial ECG monitor 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. Motion is varied randomly by rubbing or tapping. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.

    Run 2 starts with a stabilized period at 100 percent oxygen (%O2) and is followed by stabilized plateaus at various lower saturation level targets:

    100 percent, 95 percent, 85 percent, 75 percent

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 5 subjects will be recruited to complete the study. Of these, 2 will be dark pigmented.
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:

  • Age below 18 or over 50
  • Pregnant women
  • Significant arrhythmia
  • Blood pressure above 150 systolic or 90 diastolic
  • 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): NCT04814342


Locations
Layout table for location information
United States, California
UCSF Hypoxia Research Laboratory
San Francisco, California, United States, 94133
Sponsors and Collaborators
Nihon Kohden
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Philip Bickler, MD, PhD UCSF Hypoxia Research Laboratory
Layout table for additonal information
Responsible Party: Nihon Kohden
ClinicalTrials.gov Identifier: NCT04814342    
Other Study ID Numbers: 70Ag_Vital-00008
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data to be used by Sponsor only

Layout table for additional information
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:
Layout table for MeSH terms
Hypoxia
Signs and Symptoms, Respiratory