SurgeryNCT05690633
Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx
A study testing Pulse oximetry in people with Surgery and Arterial Catheterization, Peripheral, run by Joseph D. Tobias at 1 site in United States.
Trial summary
This is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Arterial Catheterization, Peripheral
- What is being tested?
- Pulse oximetry
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2024to 27 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula
Who cannot join
- Patients in whom an arterial cannula is not indicated for the surgical procedure
- Patients in whom a peripheral pulse oximeter value cannot be obtained
- Patients in whom an invasive arterial cannula cannot be placed
- Patients with any type of intra-oral pathology or injury
- Patients in whom access to the oropharynx is restricted or not feasible for any clinical reason
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 study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.
- Conditions
- Surgery, Arterial Catheterization, Peripheral
- Being tested
- Pulse oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximetryDevice
Noninvasive method of measuring the saturation of oxygen in the blood.
| Study group | Role | What they receive |
|---|---|---|
| Palate | Experimental | The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx. Receives: Device: Pulse oximetry |
| Tongue | Experimental | The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx. Receives: Device: Pulse oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal vs Extremity Saturation
Difference between the average oropharyngeal oxygen saturation and the average extremity oxygen saturation which were recorded every 2 minutes for a total of 30 minutes.
Measured: Baseline
ABG PaO2
The arterial blood gas (ABG) partial pressure of oxygen (PaO2) collected at the same time as the oropharyngeal oxygen saturation (SpO2) recording.
Measured: Baseline
Oropharyngeal SpO2
The oropharyngeal oxygen saturation (SpO2) recorded at the same time as the arterial blood gas (ABG) partial pressure of oxygen (PaO2) collection.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start9 Jan 2024
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690633
- Sponsor's protocol ID
- STUDY00003039
- Status last verified
- Mar 2026
- First submitted
- 10 Jan 2023
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Syed H, Villalobos EE, Kitio SAY, Hall B, Bryant J, Tobias JD. Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx. Paediatr Anaesth. 2025 Oct;35(10):816-821. doi: 10.1111/pan.70023. Epub 2025 Jul 31.
PubMed 40742001
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx
- ClinicalTrials.gov ID
- NCT05690633
- Acronym / sponsor ID
- STUDY00003039
- Conditions
- Surgery, Arterial Catheterization, Peripheral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Posted 13 May 2026
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 study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palate | Experimental | Device: Pulse oximetryThe use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx. |
| Tongue | Experimental | Device: Pulse oximetryThe use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula
Key exclusion criteria (5 listed)
- Patients in whom an arterial cannula is not indicated for the surgical procedure
- Patients in whom a peripheral pulse oximeter value cannot be obtained
- Patients in whom an invasive arterial cannula cannot be placed
- Patients with any type of intra-oral pathology or injury
- Patients in whom access to the oropharynx is restricted or not feasible for any clinical reason
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 oximetryNoninvasive method of measuring the saturation of oxygen in the blood. | Device | Palate, Tongue |
Primary outcome
Oropharyngeal vs Extremity Saturation
Time frame: Baseline
Difference between the average oropharyngeal oxygen saturation and the average extremity oxygen saturation which were recorded every 2 minutes for a total of 30 minutes.
ABG PaO2
Time frame: Baseline
The arterial blood gas (ABG) partial pressure of oxygen (PaO2) collected at the same time as the oropharyngeal oxygen saturation (SpO2) recording.
Oropharyngeal SpO2
Time frame: Baseline
The oropharyngeal oxygen saturation (SpO2) recorded at the same time as the arterial blood gas (ABG) partial pressure of oxygen (PaO2) collection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40742001Syed H, Villalobos EE, Kitio SAY, Hall B, Bryant J, Tobias JD. Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx. Paediatr Anaesth. 2025 Oct;35(10):816-821. doi: 10.1111/pan.70023. Epub 2025 Jul 31.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximetry in people with Surgery and Arterial Catheterization, Peripheral, run by Joseph D. Tobias 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 5 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: finished, as of the sponsor's last update on 13 May 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?
Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Oropharyngeal vs Extremity Saturation (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05690633, 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 13 May 2026.