SpO2 Accuracy in Children

Nihon Kohden

Status

Invitation-only

Conditions

Hypoxemia

Treatments

Device: Pulse oximeter

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07168798

25-023147

Details and patient eligibility

About

Evaluation of SpO2 Accuracy in Children with Various Skin Color

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

Under 12 years old

Volunteers

Accepts Healthy Volunteers

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.