The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974488
• Other study ID #: 20221246
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: University of Miami
• Contact: Fouad G Souki, MD
• Phone: (305) 5857435
• Email: fsouki[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

Device:
• McMurray Enhanced Airway
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
Participants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit.

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of subclinical hypoxia	Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.	during procedure (up to 60 minutes)
Secondary	Incidence of severe Hypoxia	Determine the incidence of severe hypoxia defined as SPo2<75%.	during procedure (up to 60 minutes)