SpO2 Accuracy in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-12

Study Completion Date

2028-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of SpO2 Accuracy in Children with Various Skin Color

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Verification of Pulse Oximetry in Neonatal Population

NCT00751439

Respiratory Distress Syndrome

COMPLETED

Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

NCT06142019

Hypoxia Skin Pigmentation

RECRUITING

The Performance of Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels

NCT00854048

Cardiopulmonary Bypass

COMPLETED

Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO17)

NCT05745662

Hypoxia

COMPLETED

Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18)

NCT05807464

Hypoxia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enrolled subjects

Subjects who meet the enrollment criteria

Pulse oximeter

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulse oximeter

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes