SGA for TEE: Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease.

Study Overview
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Brief Summary
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Increasingly, transesophageal echos (TEEs) are being done on high risk patients. A TEE is a short procedure done with deep sedation, but poses an increased risk of apnea/ hypoxemia in those with pulmonary disease. It is desirable to avoid intubation, which adds risk. Use of supraglottic airway (SGA) may offer an alternative. The investigators hypothesize that TEEs can be done successfully with an SGA in place. The investigators propose a prospective RCT to compare TEE exams done with deep sedation to those done with an SGA.

Detailed Description
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Increasingly, non-operating room anesthesia (NORA) cases are being performed on patients with high risk for needing advanced airway management, ie patients with morbid obesity, chronic hypoxemic lung disease, obstructive sleep apnea. Transesophageal echocardiography (TEE) exams are one example of this. While a TEE is typically a short, diagnostic procedure done with deep sedation, deep sedation poses an increased risk of hypoventilation and hypoxemia in patients with cardiopulmonary disease. It is desirable to avoid endotracheal intubation for TEE exams, as the procedure is short and can easily be done without muscle relaxation. Moreover, securing the airway with an endotracheal tube (ETT) is not without significant risk. The use of a supraglottic airway (SGA) may offer an alternative for patients receiving a TEE who are high risk candidates for deep sedation with a natural airway. The investigators hypothesize that the TEE procedure can be done successfully, without interruption, with an SGA in place. Our secondary hypothesis is that SGA use in high-risk patients may be safer than deep sedation, as there may be less episodes of hypoventilation and hypoxemia. The investigators propose a prospective randomized control trial to compare TEE exams done with deep sedation (control group) to those done with SGA (intervention group). Our primary outcome will be TEE study completion, and secondary outcomes will focus on the safety profile of the two groups.

Official Title
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Supraglottic Airway Use for Transesophageal Echocardiography: a Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease. (SGA-TEE)

Conditions
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Cardiopulmonary Disease

Intervention / Treatment
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* Procedure: TEE with SGA
* Procedure: TEE with Deep Sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults presenting for elective outpatient TEE examinations at UF Shands hospital during the study duration Exclusion Criteria: Known or suspected difficult airway, patient refusal or inability to consent, patients to have emergent or urgent TEE exams, patients considered to have full stomach ie gastroparesis or achalasia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Deep sedation with propofol and natural airway | Procedure: TEE with Deep Sedation<br>* Deep sedation with propofol and natural airway<br>|
| Experimental: Experimental Group<br>SGA Placement and maintenance with inhalational anesthetic or propofol | Procedure: TEE with SGA<br>* SGA Placement and maintenance with inhalational anesthetic or propofol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of successfully completed TEE examinations with the assigned airway intervention | The primary outcome is a binary data point (yes/no) defined as the success of using the assigned LMA or natural airway successfully for a TEE procedure. | Duration of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Placement of LMA | Defined by placement of LMA on first attempt, with good chest rise on positive pressure assisted ventilation, no audible leak on assisted ventilation with cuff pressure <32 cm H2O, and sustained, square waveform capnography | Duration of procedure | 
| Alternative Airway device | this secondary outcome is a binary data point (yes/no) on the use of an endotracheal tube for rescue from failure of assigned airway type for the procedure (LMA vs natural airway with sedation) | Duration of procedure | 
| Dislocation of LMA | this secondary outcome is a binary data point (yes/no) for any form of dislocation of the LMA during the endoscopic procedure necessitating repositioning of the LMA. | Duration of procedure | 
| Chin Lift or Jaw Thrust | this secondary outcome is a binary data point (yes/no) for the need to perform chin lift or jaw thrust to maintain a patent airway. | Duration of Procedure | 
| Pharyngeal Bleeding | the incidence of pharyngeal bleeding during placement or after the procedure | Duration of Procedure | 
| Hypoxia | Hypoxia during the procedure will be defined as an oxygen saturation (SpO2) <92% for more than 5 minutes. Regurgitation defined by visualized gastric contents requiring suctioning Aspiration defined by desaturation after regurgitation with suspicion of the anesthesiologist or CRNA that aspiration occurred. | Duration of Procedure | 
| Aspiration | Aspiration will be defined by desaturation (SpO2 <92) after regurgitation and inhalation of the gastric contents. | Duration of Procedure | 
| Duration of the endoscopic procedure | Insertion to removal of TEE probe | Duration of Procedure | 
| Sore throat | As described on a numerical rating scale, and at time 0, 2, and 24 hours 0= no sore throat , 1= mild sore throat, 2= moderate sore throat, 3= severe sore throat | Duration of procedure up to 24 hours after the procedure ends. | 
| Ease and comfort of advancing and operating the Endoscope by attending endoscopist | The comfort of advancing and operating the endoscope rated by the attending endoscopist after the procedure via a 5 point Likert-type scale (0 = not at all satisfied, 1=slightly satisfied, 2=moderately satisfied, 3=very satisfied, 4 = completely satisfied). | Duration of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEE, SGA, Anesthesia, sedation, Chronic Hypoxemic lung Disease, Obstructive Sleep Apnea, Morbid Obesity