Supraglottic Airway Use for Transesophageal Echocardiography: a Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease. (SGA-TEE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiopulmonary Disease
- Sponsor
- University of Florida
- Locations
- 1
- Primary Endpoint
- The number of successfully completed TEE examinations with the assigned airway intervention
- Status
- Withdrawn
- Last Updated
- last year
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.
Investigators
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
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)