The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

The Efficacy of Distal Pharyngeal Airway in Enhancing Oxygenation During Transesophageal Echocardiography (TEE) in Patients Sedated With Propofol

The purpose of this study is to investigate the effect of using the McMurray Enhanced Airway (MEA) which is a flexible extended-length distal pharyngeal airway on improving oxygen delivery compared to standard nasal cannula.

Study Overview

• Status: Recruiting
• Conditions: Airway Obstruction
• Intervention / Treatment: Device: McMurray Enhanced Airway; Device: Nasal Cannula

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fouad G Souki, MD; Phone Number: (305) 5857435; Email: fsouki@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Jackson Memorial Hospital
      • Principal Investigator: Fouad G Souki, MD
      • Contact: Fouad G Souki, MD; Phone Number: 3055857435; Email: fsouki@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > or = 18 years old
• Patients willing to participate and provide an informed consent
• Patients scheduled to undergo an elective TEE procedure.

Exclusion Criteria:

• Patients with history of uncontrolled gastroesophageal reflux disease
• Patients with anatomical airway obstruction
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distal Pharyngeal Airway; Participants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes.	Device: McMurray Enhanced Airway; The MEA is non-sterile. It can be used in inpatient or outpatient surgery, in hospital or clinic settings, or in an emergency setting. The MEA has five parts: an optional 15 mm connector, flange (color-coded for size), elongated cushioned bite block, flexible cannula, and distal tip, and a channel to allow for passage of air and a suction catheter. The MEA is designed to open and maintain a patient's upper airway. Oxygen will be delivered through the breathing circuit with the following parameters: 40% oxygen at 6 liters/min flow throughout the procedure time. The MEA will be placed in the participant's oropharyngeal airway one time during an in-person visit.
Active Comparator: Nasal cannula group; Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.	Device: Nasal Cannula; Participants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxia	Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.	during procedure (up to 60 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of subclinical hypoxia	Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.	during procedure (up to 60 minutes)
Incidence of severe Hypoxia	Determine the incidence of severe hypoxia defined as SPo2<75%.	during procedure (up to 60 minutes)

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Fouad G Souki, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction; Equipment and Supplies; Catheters; Cannula
• Other Study ID Numbers: 20221246

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