Supraglottic Airway Use for Transesophageal Echocardiography: a Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease. (SGA-TEE)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The number of successfully completed TEE examinations with the assigned airway intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Randomization to control group- deep sedation with propofol and natural airway or Experimental group-SGA Placement and maintenance with inhalational anesthetic or propofol.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults presenting for elective outpatient TEE examinations at UF Shands hospital during the study duration
排除标准
- •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
结局指标
主要结局
The number of successfully completed TEE examinations with the assigned airway intervention
时间窗: 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.
次要结局
- 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)