SpO2 Accuracy in Children

November 19, 2025 updated by: Nihon Kohden

Evaluation of SpO2 Accuracy in Children With Various Skin Color

Evaluation of SpO2 Accuracy in Children with Various Skin Color

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Pulse oximeters, which estimate blood oxygen levels, are routinely utilized for monitoring. However, research has shown that these devices may provide higher readings for individuals with darker skin tones as compared to individuals with lighter skin tones. This inaccuracy can result in unnoticed or untreated low oxygen levels, particularly affecting racial and ethnic minorities. It is beneficial for patients and healthcare providers to evaluate the accuracy of pulse oximeter oxygen saturation (SpO2) readings from pulse oximeters sold in the U.S. This study test the Nihon Kohden pulse oximeter and SpO2 sensors in neonatal and pediatric patients.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Childrens Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children in hospital setting

Description

Inclusion Criteria:

  • Children aged 0 - 12 who are admitted to the CICU with or plan to have an indwelling arterial line for standard care

Exclusion Criteria:

  • Patients with elevated levels of methemoglobin and carboxyhemoglobin, or anemia.
  • Patients with prolonged hypotension at the time of enrollment.
  • Patients with ductal-dependent congenital cardiac disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enrolled subjects
Subjects who meet the enrollment criteria
Device: Pulse oximeter
OLV-4201 pulse oximeter with sensors: TL-272T3, TL-274T3 and TL-273T3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SpO2 accuracy
Time Frame: 24 hours
Evaluate the accuracy of Nihon Kohden SpO2 in measuring blood oxygen levels in children with varying skin tones
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SpO2 to SaO2 agreement
Time Frame: 24 hours
Evaluate the agreement between Nihon Kohden SpO2 and arterial oxygen saturation (SaO2) in children with varying skin tones
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon Kohden

Collaborators

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Maryam Y Naim, M.D., MSCE, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

September 4, 2025

First Submitted That Met QC Criteria

September 4, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-023147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Proprietary information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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