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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05690633
Other study ID # STUDY00003039
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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