Accuracy of Pulse Oximeters With Profound Hypoxia at Rest (NIHO13)

• ClinicalTrials.gov Identifier: NCT04814823
• Recruitment Status: Enrolling by invitation
• First Posted: March 24, 2021
• Last Update Posted: March 30, 2021
• Sponsor: Nihon Kohden
• Collaborator: University of California, San Francisco
• Information provided by (Responsible Party): Nihon Kohden

Study Description

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 12 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Determination of SpO2 and PR Accuracy Specifications at Rest Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
• Actual Study Start Date: March 24, 2021
• Estimated Primary Completion Date: March 22, 2022
• Estimated Study Completion Date: March 21, 2023

Groups and Cohorts

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: 01-11)

Outcome Measures

Primary Outcome Measures :

1. Deviation of device SpO2 measurement with room air stabilization from co-oximeter SaO2 measurement at varying desaturation levels (Run 1) [ 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 starts with a stabilized period at room air and is followed by stabilized plateaus at various lower saturation level targets:

   room air, 92%, 87%, 82%, 77%, 72%

   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. Deviation of device SpO2 measurement with 100% oxygen stabilization from co-oximeter SaO2 measurement at varying desaturation levels (Run 2) [ 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 2 starts with a stabilized period at 100% oxygen and is followed by stabilized plateaus at various lower 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.

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. 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, 92%, 87%, 82%, 77%, 72%

   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% 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. 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% oxygen and is followed by stabilized plateaus at various lower saturation level targets:

   100%, 93%, 88%, 83%, 78%, 73%

   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.

Eligibility Criteria

• 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:

• Age below 18 or over 50
• 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

Contacts and Locations

Locations

United States, California

UCSF Hypoxia Research Laboratory

San Francisco, California, United States, 94133

Sponsors and Collaborators

Nihon Kohden

University of California, San Francisco

Investigators

• Principal Investigator: Philip Bickler, MD, PhD; UCSF Hypoxia Research Laboratory

More Information

• Responsible Party: Nihon Kohden
• ClinicalTrials.gov Identifier: NCT04814823
• Other Study ID Numbers: 70Ag_Vital-00007
• First Posted: March 24, 2021
• 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

• 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:

Hypoxia; Signs and Symptoms, Respiratory