The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

NCT ID: NCT05974488

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Airway Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

McMurray Enhanced Airway

Intervention Type 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.

Nasal cannula group

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

Group Type ACTIVE_COMPARATOR

Nasal Cannula

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Fouad souki

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fouad G Souki, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Jackson Memorial Hospital

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Fouad G Souki, MD

Role: CONTACT

(305) 5857435

Facility Contacts

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Fouad G Souki, MD

Role: primary

3055857435

Other Identifiers

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20221246

Identifier Type: -

Identifier Source: org_study_id

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