HypoxemiaNCT07168798
SpO2 Accuracy in Children
An observational study of Hypoxemia, run by Nihon Kohden at 1 site in United States.
Trial summary
Evaluation of SpO2 Accuracy in Children with Various Skin Color Read more about this study
- Who is it for?
- Ages 0 days to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Pulse oximeter
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children in hospital setting
Who may be able to join
- Children aged 0 - 12 who are admitted to the CICU with or plan to have an indwelling arterial line for standard care
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of SpO2 Accuracy in Children With Various Skin Color
Evaluation of SpO2 Accuracy in Children with Various Skin Color
Read the 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.
- Conditions
- Hypoxemia
- Being tested
- Pulse oximeter
- Keywords
- Spo2, Pulse oximetry, skin tone
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterDevice
OLV-4201 pulse oximeter with sensors: TL-272T3, TL-274T3 and TL-273T3
| Study group | Role | What they receive |
|---|---|---|
| Enrolled subjects | Subjects who meet the enrollment criteria Receives: Device: Pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 accuracy
Evaluate the accuracy of Nihon Kohden SpO2 in measuring blood oxygen levels in children with varying skin tones
Measured: 24 hours
Secondary outcomes (1)
SpO2 to SaO2 agreement
Evaluate the agreement between Nihon Kohden SpO2 and arterial oxygen saturation (SaO2) in children with varying skin tones
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start12 Nov 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon Kohden
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Maryam Y Naim, M.D., MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168798
- Sponsor's protocol ID
- 25-023147
- Status last verified
- Nov 2025
- First submitted
- 4 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Proprietary information
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.
PubMed 33326721
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SpO2 Accuracy in Children With Various Skin Color
- ClinicalTrials.gov ID
- NCT07168798
- Acronym / sponsor ID
- 25-023147
- Conditions
- Hypoxemia
- Keywords
- Spo2, Pulse oximetry, skin tone
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nihon KohdenIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled subjects | – | Device: Pulse oximeterSubjects who meet the enrollment criteria |
Who may qualify
- Ages
- 0 days to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children in hospital setting
Key inclusion criteria (1 listed)
- Children aged 0 - 12 who are admitted to the CICU with or plan to have an indwelling arterial line for standard care
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse oximeterOLV-4201 pulse oximeter with sensors: TL-272T3, TL-274T3 and TL-273T3 | Device | Enrolled subjects |
Primary outcome
SpO2 accuracy
Time frame: 24 hours
Evaluate the accuracy of Nihon Kohden SpO2 in measuring blood oxygen levels in children with varying skin tones
1 secondary outcome
SpO2 to SaO2 agreement
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 33326721Sjoding 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.
- Individual participant dataSharing planned: No. Proprietary information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maryam Y Naim, M.D., MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia, run by Nihon Kohden at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 accuracy (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07168798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.