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Clinical Trials/NCT04939220
NCT04939220WithdrawnNot Applicable

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

University of Florida1 site in 1 countryStarted: February 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
The number of successfully completed TEE examinations with the assigned airway intervention

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Randomization to control group- deep sedation with propofol and natural airway or Experimental group-SGA Placement and maintenance with inhalational anesthetic or propofol.

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Control Group

Active Comparator

Deep sedation with propofol and natural airway

Intervention: TEE with Deep Sedation (Procedure)

Experimental Group

Experimental

SGA Placement and maintenance with inhalational anesthetic or propofol

Intervention: TEE with SGA (Procedure)

Outcomes

Primary Outcomes

The number of successfully completed TEE examinations with the assigned airway intervention

Time Frame: Duration of procedure

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.

Secondary Outcomes

  • Ease of Placement of LMA(Duration of procedure)
  • Sore throat(Duration of procedure up to 24 hours after the procedure ends.)
  • Alternative Airway device(Duration of procedure)
  • Chin Lift or Jaw Thrust(Duration of Procedure)
  • Hypoxia(Duration of Procedure)
  • Aspiration(Duration of Procedure)
  • Dislocation of LMA(Duration of procedure)
  • Pharyngeal Bleeding(Duration of Procedure)
  • Duration of the endoscopic procedure(Duration of Procedure)
  • Ease and comfort of advancing and operating the Endoscope by attending endoscopist(Duration of procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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