A Randomized Study to Compare LMA® Gastro™, a Dual Channel Supraglottic Airway (SGA) Device, to Oxygenation With Standard Nasal Cannula for Endoscopic Retrograde Cholangiopancreatography (ERCP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Number of Participants That Had Desaturation Episodes of SpO2 <90%
研究概览
简要总结
This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.
详细描述
PRIMARY OBJECTIVE:
I. To compare the incidence of desaturation (oxygen saturation [SpO2] < 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of additional airway maneuvers (jaw thrust/chin lift/placement of oral airway or/nasal trumpet/intubation).
II. To evaluate the incidence of withdrawal of duodenoscope from the airway to facilitate airway support.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>= 18 years old) undergoing ERCP
排除标准
- •Patients with propofol allergy
- •Patients at increased aspiration risk
- •Patients with abnormal head/neck pathology preventing LMA Gastro placement
- •Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
- •Patient with known difficult airway requiring advanced intubation equipment (with the exception of the video-laryngoscope) in the past
- •Esophagectomy patients
- •Patients already intubated upon arrival to endoscopy suite
- •Patients undergoing endoscopic ultrasound (EUS)
- •Patients with body mass index (BMI) >= 35 kg/m^2
- •Patients with hypoxemia (SpO2 < 94% on room air or on home oxygen)
- •American Society of Anesthesiology (ASA) Physical Status IV-V
结局指标
主要结局
Number of Participants That Had Desaturation Episodes of SpO2 <90%
时间窗: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
The desaturation (SpO2 \< 90%) between patients undergoing ERCP with LMA® Gastro™ vs standard nasal cannula
次要结局
- Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support(The time between Anesthesia Start time and Anesthesia End time)
- Incidence of Adverse Events(From PACU arrival to PACU discharge, 3 hours in average)
- To Evaluate Times Related to Anesthesia and Procedure(From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutes)
- To Evaluate Time From Procedure End to Anesthesia End(From procedure end and anesthesia end, up to 60 minutes)
- To Describe Heart Rates Within the Two Groups(From "anesthesia start" to "anesthesia end", on average 5 hours)
- To Describe Oxygen Saturations Within the Two Groups(From "anesthesia start" to "anesthesia end", on average 5 hours)
- Incidence of Additional Airway Maneuvers(The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average)
- To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups(From "anesthesia start" to "anesthesia end", on average 5 hours)
- To Evaluate Anesthesiologist Placing the Device(At the end of procedure, between 5 - 10 minutes)