The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

Not Applicable

Recruiting

• Conditions: Airway Obstruction
• Interventions: Device: Nasal Cannula; Device: McMurray Enhanced Airway

• Registration Number: NCT05974488
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-03
• Study Start: 2023-11-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal cannula group	Nasal Cannula	Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.
Distal Pharyngeal Airway	McMurray Enhanced Airway	Participants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes.

Primary Outcome Measures

Name	Time	Method
Incidence of hypoxia	during procedure (up to 60 minutes)	Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.

Secondary Outcome Measures

Name	Time	Method
Incidence of severe Hypoxia	during procedure (up to 60 minutes)	Determine the incidence of severe hypoxia defined as SPo2\<75%.
Incidence of subclinical hypoxia	during procedure (up to 60 minutes)	Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.

Trial Locations

Locations (1)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States