What side effects are associated with this type of intervention?

Common treatments for airway blockage, such as nasal cannulas, laryngeal mask airways (LMAs), and endotracheal intubation, can have several side effects. Nasal cannulas may cause nasal dryness and irritation. LMAs are generally well-tolerated but can occasionally lead to sore throat, hoarseness, or minor airway trauma. Endotracheal intubation, while effective, carries risks such as bronchoconstriction, sore throat, vocal cord damage, and, in rare cases, more severe complications like acute respiratory failure. The McMurray Enhanced Airway (MEA), being a flexible extended-length distal pharyngeal airway, aims to improve oxygen delivery and may share similar side effects, primarily related to airway irritation and discomfort.

What prior FDA approvals exist?

The FDA has approved several devices and treatments for airway blockage that aim to improve oxygen delivery. These include various types of airway adjuncts such as nasal cannulas, oropharyngeal airways, and endotracheal tubes. Additionally, Continuous Positive Airway Pressure (CPAP) devices are commonly used to maintain open airways in conditions like obstructive sleep apnea. While specific information on devices exactly like the McMurray Enhanced Airway is limited, these approved treatments share the common goal of enhancing oxygenation and maintaining airway patency.

What other types of research exist?

Promising alternatives to the McMurray Enhanced Airway for airway blockage patients include: 1) High-flow nasal cannula (HFNC) systems, which provide heated and humidified oxygen at high flow rates, improving oxygenation and reducing work of breathing. 2) Supraglottic airway devices (e.g., i-gel, LMA Supreme), which are easy to insert and provide effective ventilation without the need for tracheal intubation. 3) Video laryngoscopes, which enhance visualization of the airway and facilitate intubation in difficult airway scenarios. These alternatives have shown efficacy in improving oxygen delivery and patient outcomes in recent studies.

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Procedure

Distal Pharyngeal Airway for Oxygenation During Procedures

N/A

Recruiting

Led By Fouad G Souki, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled to undergo an elective TEE procedure.

Age > or = 18 years old

Must not have

Patients with history of uncontrolled gastroesophageal reflux disease

Patients with anatomical airway obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during procedure (up to 60 minutes)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new flexible tube called the McMurray Enhanced Airway (MEA) to help people breathe better. It aims to see if this tube can deliver oxygen more effectively than the usual method. The MEA is designed to reach deeper into the throat, which might improve oxygen levels in patients who need it.

Who is the study for?

This trial is for adults aged 18 or older who are scheduled for an elective Transesophageal Echocardiography (TEE) procedure and can give informed consent. It's not suitable for those with uncontrolled acid reflux or anatomical airway blockages, or any condition that might interfere with the study.

What is being tested?

The study is testing if the McMurray Enhanced Airway (MEA), a special flexible airway device, provides better oxygenation during TEE than the standard nasal cannula, which is a tube placed in the nostrils.

What are the potential side effects?

Potential side effects may include discomfort from using MEA, possible sore throat after use, and rare risks associated with airway manipulation such as minor bleeding or injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a TEE (heart ultrasound) procedure.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have uncontrolled acid reflux.

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I have a blockage in my airways.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during procedure (up to 60 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during procedure (up to 60 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure (up to 60 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of hypoxia

Secondary study objectives

Incidence of severe Hypoxia

Incidence of subclinical hypoxia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Distal Pharyngeal AirwayExperimental Treatment1 Intervention

Participants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes.

Group II: Nasal cannula groupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

McMurray Enhanced Airway

2019

N/A

~90

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The McMurray Enhanced Airway (MEA) and similar devices improve oxygen delivery by maintaining an open airway, preventing collapse, and ensuring continuous airflow. This is vital for patients with airway blockage as it helps maintain adequate oxygenation, reduces the work of breathing, and prevents complications such as hypoxemia. Other treatments like CPAP devices and surgical interventions like adenotonsillectomy also aim to keep the airways open, thereby improving quality of life and health outcomes.

Prospective validation of a new airway management algorithm and predictive features of intubation difficulty.Does glycopyrrolate premedication facilitate tracheal intubation with a rigid video-stylet?: A randomized controlled trial.The effect of tulobuterol patches on the respiratory system after endotracheal intubation.