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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05974488
Other study ID # 20221246
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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