SGA for TEE: Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease.
- Conditions
- Cardiopulmonary Disease
- Interventions
- Procedure: TEE with Deep SedationProcedure: TEE with SGA
- Registration Number
- NCT04939220
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Adults presenting for elective outpatient TEE examinations at UF Shands hospital during the study duration
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group TEE with Deep Sedation Deep sedation with propofol and natural airway Experimental Group TEE with SGA SGA Placement and maintenance with inhalational anesthetic or propofol
- Primary Outcome Measures
Name Time Method The number of successfully completed TEE examinations with the assigned airway intervention 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 Outcome Measures
Name Time Method Ease of Placement of LMA Duration of procedure 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
Sore throat Duration of procedure up to 24 hours after the procedure ends. 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
Alternative Airway device Duration of procedure 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)
Chin Lift or Jaw Thrust Duration of Procedure 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.
Hypoxia Duration of Procedure 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.Aspiration Duration of Procedure Aspiration will be defined by desaturation (SpO2 \<92) after regurgitation and inhalation of the gastric contents.
Dislocation of LMA Duration of procedure 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.
Pharyngeal Bleeding Duration of Procedure the incidence of pharyngeal bleeding during placement or after the procedure
Duration of the endoscopic procedure Duration of Procedure Insertion to removal of TEE probe
Ease and comfort of advancing and operating the Endoscope by attending endoscopist Duration of procedure 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).
Trial Locations
- Locations (1)
UF Health Jacksonville
🇺🇸Jacksonville, Florida, United States