Feasibility of Obtaining Pulse Oximetry Readings from the Oropharynx

NCT05690633 | Completed FDA Device

• 1 other identifier: STUDY00003039
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Accuracy of Pulse Oximetry

  Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations

  Baseline

Study Arms (1)

Oropharyngeal oximetry

EXPERIMENTAL

The use of a pulse oximeter in the oropharynx on either an oral airway or a tongue blade.

Device: Pulse oximetry

Interventions

Pulse oximetry DEVICE

Noninvasive method of measuring the saturation of oxygen in the blood.

Oropharyngeal oximetry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Oximetry

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: January 9, 2024
• Primary Completion: January 27, 2025
• Study Completion: January 27, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)