- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05690633
Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx
April 21, 2026 updated by: Joseph D. Tobias
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Palate
The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx.
|
Noninvasive method of measuring the saturation of oxygen in the blood.
|
|
Experimental: Tongue
The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx.
|
Noninvasive method of measuring the saturation of oxygen in the blood.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2024
Primary Completion (Actual)
January 27, 2025
Study Completion (Actual)
January 27, 2025
Study Registration Dates
First Submitted
January 10, 2023
First Submitted That Met QC Criteria
January 10, 2023
First Posted (Actual)
January 19, 2023
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
April 21, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Respiratory System
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Respiratory Function Tests
- Blood Chemical Analysis
- Clinical Chemistry Tests
- Blood Gas Analysis
- Oximetry
Other Study ID Numbers
- STUDY00003039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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