The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05974488
Status
Recruiting
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Conditions

  • Airway Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 30, 2023
Status verified
Sep 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Active Comparator: Nasal cannula group
    Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.

Primary Outcome Measure

Incidence of hypoxia [ Time Frame: during procedure (up to 60 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jackson Memorial HospitalMiamiFlorida33136
Fouad G Souki, MD
[email protected]
3055857435
Fouad G Souki, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Jackson Memorial Hospital· Miami, FL

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