The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

Study Overview
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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.

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

Conditions
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Airway Obstruction

Intervention / Treatment
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* Device: McMurray Enhanced Airway
* Device: Nasal Cannula


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal Pharyngeal Airway<br>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<br>* 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.<br>|
| Active Comparator: Nasal cannula group<br>Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes. | Device: Nasal Cannula<br>* Participants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit.<br>|

What is the study measuring?
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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) |