SurgeryNCT05692453
Pulse Oximetry Accuracy by Skin Color
An observational study of Surgery, run by Brittany Willer at 1 site in United States.
Trial summary
This is a prospective, non-randomized, non-blinded comparative study to evaluate the accuracy of pulse oximetry compared to co-oximetry in dark-skinned (Black) compared to lighter-skinned (White) children undergoing anesthesia, using standard FDA performance statistics as measured by mean bias and accuracy root mean… Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Surgery
- What is being tested?
- Arterial blood gas with co-oximetry
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Dec 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing surgery at Nationwide Children's Hospital.
Who may be able to join
- Children aged 2-9 years undergoing general anesthesia with or without arterial line placement.
Who cannot join
- Patients with cyanotic congenital heart disease.
- Patients with bleeding disorders.
- Patients taking blood thinners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is a prospective, non-randomized, non-blinded comparative study to evaluate the accuracy of pulse oximetry compared to co-oximetry in dark-skinned (Black) compared to lighter-skinned (White) children undergoing anesthesia, using standard FDA performance statistics as measured by mean bias and accuracy root mean squared to evaluate device performance.
Read the detailed description
This is a prospective, non-randomized, non-blinded comparative study.
There will be no changes to the anesthetic or surgical plan to accommodate this study. Patients undergoing anesthesia will be induced per their anesthetic team. Following endotracheal intubation, the patient will be placed on air (FiO2 21%) at 4 liters per minute fresh gas flow. After a minimum of 3 minutes has elapsed, the anesthesia team will obtain an arterial blood sample of approximately 1 mL. This can be obtained from an arterial line if one is planned for the procedure or already in place by accessing the line per standard procedure. If an arterial line is not placed, the arterial sample will be obtained by percutaneous arterial puncture using ultrasound guidance and a 25-gauge blood gas syringe. The patient's SpO2 will be noted using a pulse oximetry probe placed on the right index finger when the arterial sample is drawn, along with the date/time of sample acquisition. Once the sample is drawn, the patient's anesthetic and surgery will proceed as per his anesthesia team. The arterial sample will be immediately delivered to the Nationwide Children's Hospital laboratory for simultaneous ABG and ABG-CoOx analysis to obtain SaO2S and SaO2C, respectively.
- Conditions
- Surgery
- Being tested
- Arterial blood gas with co-oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood gas with co-oximetryDiagnostic test
Also called ABG-CoOx
1 mL blood sample for ABG-CoOx analysis to obtain co-oximetry measured arterial oxygen saturation (SaO2C) and standard ABG derived arterial oxygen saturation (SaO2S).
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Pulse Oximetry
Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations measured by arterial blood gas with co-oximetry (ABG-CoOx).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: No funding to pay for lab tests.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brittany Willer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brittany Willer, Nationwide Children's Hospital
- Investigators
- Brittany Willer, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692453
- Sponsor's protocol ID
- STUDY00003117
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximetry Accuracy by Skin Color
- ClinicalTrials.gov ID
- NCT05692453
- Acronym / sponsor ID
- STUDY00003117
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding to pay for lab tests.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brittany WillerUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jan 2023 (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.
This is a prospective, non-randomized, non-blinded comparative study to evaluate the accuracy of pulse oximetry compared to co-oximetry in dark-skinned (Black) compared to lighter-skinned (White) children undergoing anesthesia, using standard FDA performance statistics as measured by mean bias and accuracy root mean squared to evaluate device performance.
Detailed description
This is a prospective, non-randomized, non-blinded comparative study.
There will be no changes to the anesthetic or surgical plan to accommodate this study. Patients undergoing anesthesia will be induced per their anesthetic team. Following endotracheal intubation, the patient will be placed on air (FiO2 21%) at 4 liters per minute fresh gas flow. After a minimum of 3 minutes has elapsed, the anesthesia team will obtain an arterial blood sample of approximately 1 mL. This can be obtained from an arterial line if one is planned for the procedure or already in place by accessing the line per standard procedure. If an arterial line is not placed, the arterial sample will be obtained by percutaneous arterial puncture using ultrasound guidance and a 25-gauge blood gas syringe. The patient's SpO2 will be noted using a pulse oximetry probe placed on the right index finger when the arterial sample is drawn, along with the date/time of sample acquisition. Once the sample is drawn, the patient's anesthetic and surgery will proceed as per his anesthesia team. The arterial sample will be immediately delivered to the Nationwide Children's Hospital laboratory for simultaneous ABG and ABG-CoOx analysis to obtain SaO2S and SaO2C, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing surgery at Nationwide Children's Hospital.
Key inclusion criteria (1 listed)
- Children aged 2-9 years undergoing general anesthesia with or without arterial line placement.
Key exclusion criteria (3 listed)
- Patients with cyanotic congenital heart disease.
- Patients with bleeding disorders.
- Patients taking blood thinners.
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 |
|---|---|---|
| Arterial blood gas with co-oximetryAlso: ABG-CoOx1 mL blood sample for ABG-CoOx analysis to obtain co-oximetry measured arterial oxygen saturation (SaO2C) and standard ABG derived arterial oxygen saturation (SaO2S). | Diagnostic test | – |
Primary outcome
Accuracy of Pulse Oximetry
Time frame: Baseline
Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations measured by arterial blood gas with co-oximetry (ABG-CoOx).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Surgery
Recruiting
Perioperative Multicomponent Rehabilitation and Outcomes in Elderly Patients With Frailty
Old Age; Debility, Digestive Cancer
Recruiting
Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
Elderly, Cancer Surgery
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruitingObservational study
Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement
ACDF Surgery
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
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. This study is not recruiting at the moment.
Brittany Willer, MD principal investigator
Nationwide Children's Hospital
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 Surgery, run by Brittany Willer 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: withdrawn, as of the sponsor's last update on 14 Sep 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Accuracy of Pulse Oximetry (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.