SpO2 Accuracy in Children

N/AEnrolling By InvitationNCT07168798

Nihon Kohden180 enrolled

Overview

Evaluation of SpO2 Accuracy in Children with Various Skin Color

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

180

Conditions

Hypoxemia

Interventions

Pulse oximeterDEVICE

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

Eligibility

Sex: ALLMin age: 0 DaysMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

SpO2 accuracy

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

Time frame: 24 hours

Secondary Outcomes

SpO2 to SaO2 agreement

Evaluate the agreement between Nihon Kohden SpO2 and arterial oxygen saturation (SaO2) in children with varying skin tones

Time frame: 24 hours

Data from ClinicalTrials.gov

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