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Enrolling by Invitation

NCT Number: NCT07168798

SpO2 Accuracy in Children

Evaluation of SpO2 Accuracy in Children with Various Skin Color

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Key information

Conditions

Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

0 day–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulse Oximeter

Device

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

Primary outcomes

  1. SpO2 accuracy

    Time frame: 24 hours

    Evaluate the accuracy of Nihon Kohden SpO2 in measuring blood oxygen levels in children with varying skin tones

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nihon Kohden

Industry

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

Evaluation of SpO2 Accuracy in Children With Various Skin Color

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 11, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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