SpO2 Accuracy in Children

Not yet recruiting

• Conditions: Hypoxemia

• Registration Number: NCT07168798
• Lead Sponsor: Nihon Kohden

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Study Start: 2025-11-01
• Primary Completion: 2027-11-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Childrens Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States