Health TrialsbyHealthPanel

The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

ConditionAirway Obstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > or = 18 years old

Patients willing to participate and provide an informed consent

Patients scheduled to undergo an elective TEE procedure.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • McMurray Enhanced Airway

    Device

    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

    Device

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Distal Pharyngeal AirwayExperimental treatment 1 intervention
Group B: Nasal cannula groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of hypoxia

Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.

Time frame
during procedure (up to 60 minutes)

Secondary outcomes

1

Incidence of subclinical hypoxia

Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.

Time frame
during procedure (up to 60 minutes)
2

Incidence of severe Hypoxia

Determine the incidence of severe hypoxia defined as SPo2\<75%.

Time frame
during procedure (up to 60 minutes)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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