Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx

Surgery Clinical Trial

Official title:

Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05690633
• Other study ID #: STUDY00003039
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Catheterization, Peripheral
• Surgery

Intervention

Device:
• Pulse oximetry
Noninvasive method of measuring the saturation of oxygen in the blood.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Pulse Oximetry	Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations	Baseline