Menu
Enrolling by invitation NCT07168798

SpO2 Accuracy in Children

— Observational Hypoxemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulse oximeter.
Who it may be relevant to
Registry conditions: Hypoxemia. Basic parameters: 0 Days — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of SpO2 Accuracy in Children With Various Skin Color

Overview

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.

Interventions

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

Primary outcome measures

  • SpO2 accuracy [Time frame: 24 hours]
Secondary outcome measures (1)
  • SpO2 to SaO2 agreement [Time frame: 24 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Childrens Hospital of Philadelphia — Philadelphia

Publications

  • Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available. PMID 33326721

Identifiers

NCT: NCT07168798 · 25-023147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗