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SpO2 Accuracy in Children

Evaluation of SpO2 Accuracy in Children With Various Skin Color

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07168798
Enrollment
180
Registered
2025-09-11
Start date
2025-11-12
Completion date
2028-11-01
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia

Keywords

Spo2, Pulse oximetry, skin tone

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.

Interventions

DEVICEPulse oximeter

OLV-4201 pulse oximeter with sensors: TL-272T3, TL-274T3 and TL-273T3

Sponsors

Children's Hospital of Philadelphia
CollaboratorOTHER
Nihon Kohden
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
SpO2 accuracy24 hoursEvaluate the accuracy of Nihon Kohden SpO2 in measuring blood oxygen levels in children with varying skin tones

Secondary

MeasureTime frameDescription
SpO2 to SaO2 agreement24 hoursEvaluate the agreement between Nihon Kohden SpO2 and arterial oxygen saturation (SaO2) in children with varying skin tones

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026