Airway Obstruction
Conditions
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.
Interventions
DEVICENasal 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.
DEVICEMcMurray 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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subclinical hypoxia | during procedure (up to 60 minutes) | Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%. |
| Incidence of severe Hypoxia | during procedure (up to 60 minutes) | Determine the incidence of severe hypoxia defined as SPo2\<75%. |
Countries
United States
Contacts
Primary ContactFouad G Souki, MD
Outcome results
None listed