SpO2 Accuracy in Children | NCT07168798

Studies
SpO2 Accuracy in Children

NCT07168798

Sponsor

Nihon Kohden

Status

Enrolling by invitation

Last Update Posted

Nov 21, 2025Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Hypoxemia

Interventions

Pulse oximeter

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 12, 2025Actual

Primary Completion Date

Nov 1, 2027Estimated

Completion Date

Nov 1, 2028Estimated

First Submitted Date

Sep 4, 2025

First Submission Date that Met QC Criteria

Sep 4, 2025

First Posted Date

Sep 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 21, 2025Actual

Name	Class
Children's Hospital of Philadelphia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of SpO2 Accuracy in Children with Various Skin Color

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enrolled subjects		Subjects who meet the enrollment criteria	Device: Pulse oximeter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulse oximeter	Device	OLV-4201 pulse oximeter with sensors: TL-272T3, TL-274T3 and TL-273T3	Enrolled subjects

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

12 Years

Standard Ages

Child

Study Population

Children in hospital setting

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maryam Y Naim, M.D., MSCE	Children's Hospital of Philadelphia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Hospital of Philadelphia		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33326721	Result	Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available.

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms