Clinical trial NCT04939220: SGA for TEE: Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease.
Official title: Supraglottic Airway Use for Transesophageal Echocardiography: a Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease. (SGA-TEE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiopulmonary Disease
Keywords: TEE
SGA
Anesthesia
sedation
Chronic Hypoxemic lung Disease
Obstructive Sleep Apnea
Morbid Obesity
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized control trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of successfully completed TEE examinations with the assigned airway intervention
timeFrame: Duration of procedure
Secondary outcomes:
measure: Ease of Placement of LMA
timeFrame: Duration of procedure
measure: Alternative Airway device
timeFrame: Duration of procedure
measure: Dislocation of LMA
timeFrame: Duration of procedure
measure: Chin Lift or Jaw Thrust
timeFrame: Duration of Procedure
measure: Pharyngeal Bleeding
timeFrame: Duration of Procedure
measure: Hypoxia
timeFrame: Duration of Procedure
measure: Aspiration
timeFrame: Duration of Procedure
measure: Duration of the endoscopic procedure
timeFrame: Duration of Procedure
measure: Sore throat
timeFrame: Duration of procedure up to 24 hours after the procedure ends.
measure: Ease and comfort of advancing and operating the Endoscope by attending endoscopist
timeFrame: Duration of procedure
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: Stefan Braunecker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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