NCT07168798

Brief Summary

Evaluation of SpO2 Accuracy in Children with Various Skin Color

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Nov 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Nov 2025Nov 2028

First Submitted

Initial submission to the registry

September 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 12, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

September 4, 2025

Last Update Submit

November 19, 2025

Conditions

Hypoxemia

Keywords

Spo2Pulse oximetryskin tone

Outcome Measures

Primary Outcomes (1)

  • SpO2 accuracy

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

    24 hours

Secondary Outcomes (1)

  • SpO2 to SaO2 agreement

    24 hours

Study Arms (1)

Enrolled subjects

Subjects who meet the enrollment criteria

Device: Pulse oximeter

Interventions

Pulse oximeterDEVICE

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

Enrolled subjects

Eligibility Criteria

Age0 Days - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children in hospital setting

You may qualify if:

  • Children aged 0 - 12 who are admitted to the CICU with or plan to have an indwelling arterial line for standard care

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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: 33326721RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maryam Y Naim, M.D., MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 11, 2025

Study Start

November 12, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Proprietary information

Locations

US(1)