NCT05690633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

January 9, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2025

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

January 10, 2023

Results QC Date

April 1, 2026

Last Update Submit

April 21, 2026

Conditions

SurgeryArterial Catheterization, Peripheral

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline

Study Arms (2)

Palate

EXPERIMENTAL

The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx.

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.

Device: Pulse oximetry

Interventions

Pulse oximetryDEVICE

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

PalateTongue

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • 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.

    PMID: 40742001DERIVED

MeSH Terms

Interventions

Oximetry

Intervention Hierarchy (Ancestors)

Blood Gas AnalysisBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Results Point of Contact

Title
Dr. Joseph Tobias
Organization
Nationwide Children's Hospital
Joseph.Tobias@nationwidechildrens.org
614-722-4200

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
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

May 13, 2026

Results First Posted

May 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)