Back to resultsThe Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE
Primary Purpose
Airway Obstruction
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
McMurray Enhanced Airway
Nasal Cannula
Sponsored by
About this trial
This is an interventional supportive care trial for Airway Obstruction
Eligibility Criteria
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
Sites / Locations
- Jackson Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Distal Pharyngeal Airway
Nasal cannula group
Arm Description
Participants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes.
Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.
Outcomes
Primary Outcome Measures
Incidence of hypoxia
Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.
Secondary Outcome Measures
Incidence of subclinical hypoxia
Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.
Incidence of severe Hypoxia
Determine the incidence of severe hypoxia defined as SPo2<75%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05974488
Brief Title
The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE
Official Title
The Efficacy of Distal Pharyngeal Airway in Enhancing Oxygenation During Transesophageal Echocardiography (TEE) in Patients Sedated With Propofol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Distal Pharyngeal Airway
Arm Type
Experimental
Arm Description
Participants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes.
Arm Title
Nasal cannula group
Arm Type
Active Comparator
Arm Description
Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.
Intervention Type
Device
Intervention Name(s)
McMurray Enhanced Airway
Intervention Description
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
Intervention Name(s)
Nasal Cannula
Intervention Description
Participants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit.
Primary Outcome Measure Information:
Title
Incidence of hypoxia
Description
Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.
Time Frame
during procedure (up to 60 minutes)
Secondary Outcome Measure Information:
Title
Incidence of subclinical hypoxia
Description
Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.
Time Frame
during procedure (up to 60 minutes)
Title
Incidence of severe Hypoxia
Description
Determine the incidence of severe hypoxia defined as SPo2<75%.
Time Frame
during procedure (up to 60 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fouad G Souki, MD
Phone
(305) 5857435
Email
fsouki@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fouad G Souki, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fouad G Souki, MD
Phone
305-585-7435
Email
fsouki@miami.edu
First Name & Middle Initial & Last Name & Degree
Fouad G Souki, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE
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