The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

NCT05974488 | Recruiting FDA Device

• 1 other identifier: 20221246
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of subclinical hypoxia

  during procedure (up to 60 minutes)

• Incidence of severe Hypoxia

  during procedure (up to 60 minutes)

Study Arms (2)

Distal Pharyngeal Airway

EXPERIMENTAL

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

Nasal cannula group

ACTIVE COMPARATOR

Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.

Device: Nasal Cannula

Interventions

McMurray Enhanced Airway DEVICE

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.

Distal Pharyngeal Airway

Nasal Cannula DEVICE

Participants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit.

Nasal cannula group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Airway Obstruction

Interventions

Cannula

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Fouad G Souki, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fouad G Souki, MD

CONTACT

(305) 5857435; fsouki@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: August 3, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)