Airway ObstructionNCT05974488
The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE
A study testing McMurray Enhanced Airway and Nasal Cannula in people with Airway Obstruction, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- McMurray Enhanced Airway and Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years old
- Patients willing to participate and provide an informed consent
- Patients scheduled to undergo an elective TEE procedure.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jackson Memorial Hospital
Miami, Florida, 33136
Fouad G Souki, MD, 3055857435, fsouki@miami.edu
Fouad G Souki, MD
About this study
Official title: 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.
- Conditions
- Airway Obstruction
- Being tested
- McMurray Enhanced Airway, Nasal Cannula
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McMurray Enhanced AirwayDevice
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 CannulaDevice
Participants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxia
Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.
Measured: during procedure (up to 60 minutes)
Secondary outcomes (2)
Incidence of subclinical hypoxia
Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.
Measured: during procedure (up to 60 minutes)
Incidence of severe Hypoxia
Determine the incidence of severe hypoxia defined as SPo2<75%.
Measured: during procedure (up to 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start30 Nov 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouad souki, University of Miami
- Investigators
- Fouad G Souki, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974488
- Sponsor's protocol ID
- 20221246
- Status last verified
- Sep 2025
- First submitted
- 31 May 2023
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Distal Pharyngeal Airway in Enhancing Oxygenation During Transesophageal Echocardiography (TEE) in Patients Sedated With Propofol
- ClinicalTrials.gov ID
- NCT05974488
- Acronym / sponsor ID
- 20221246
- Conditions
- Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal Pharyngeal Airway | Experimental | Device: McMurray Enhanced AirwayParticipants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes. |
| Nasal cannula group | Active comparator | Device: Nasal CannulaParticipant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > or = 18 years old
- Patients willing to participate and provide an informed consent
- Patients scheduled to undergo an elective TEE procedure.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McMurray Enhanced AirwayThe 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. | Device | Distal Pharyngeal Airway |
| Nasal CannulaParticipants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit. | Device | Nasal cannula group |
Primary outcome
Incidence of hypoxia
Time frame: during procedure (up to 60 minutes)
Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.
2 secondary outcomes
Incidence of subclinical hypoxia
Time frame: during procedure (up to 60 minutes)
Incidence of severe Hypoxia
Time frame: during procedure (up to 60 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fouad G Souki, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McMurray Enhanced Airway and Nasal Cannula in people with Airway Obstruction, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fouad G Souki, MD ((305) 5857435, fsouki@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxia (time frame: during procedure (up to 60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.