Anesthesiological Management of Ventilation With Laryngeal Mask in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound Procedures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Partial Pressure of Carbon Dioxide (PaCO2)
研究概览
简要总结
Diagnostic and operative procedures of upper gastrointestinal (GI) tract are very common in all patients. Some procedures are difficult to tolerate because of long duration, prone position or significant stimulation of the upper airways. An example are endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic pancreatic ultrasound.
The procedures are generally performed with deep sedation. Many pharmacologic regimens are available and described in literature. The investigator's institute adopts propofol target controlled infusion (TCI), which usually guarantees unconsciousness and unresponsiveness of patients. The main adverse event is dose-related respiratory depression. Pre-existing reasons for hypoventilation can exacerbate this event, especially in the elderly and the chronic obstructive pulmonary disease-patients. Laryngeal mask (LMA) is a useful tool to apply a pressure support ventilation. One specific type of LMA allows to separate the gastric and respiratory tract and, allows the anesthesiologist to support patient's ventilation as (and only if) necessary.
详细描述
This is a monocentric randomized controlled trial of superiority of LMA use in GI endoscopic procedures. Randomization is centralized. The study is single blind (patient). The study is no-profit. Every patients undergoing scheduled ERCP and endoscopic ultrasound will be screened and consecutive eligible patients will be enrolled. Subjects will be allocated according to a simple randomization list. The study starts after randomization and ends after discharge from the recovery room. After peripheral venous catheter insertion and vital parameters monitoring, patients will receive propofol TCI with a tailored target between 4 and 6 mcg/ml. The treatment group will receive LMA insertion and End-Tidal Carbon Dioxide (ETCO2) monitoring throughout the procedure. In case of hypoventilation, with an ETCO2 above 50 mmHg, the patient will be supported as necessary with PSV. The control group will not receive any airway device, according to the standard treatment. At the end of the procedure, both group will receive a laboratory testing (peripheral arterial sample), when the patient is still sedated. Vital parameters monitoring will continue in recovery room. Patients will be discharge as usual with an Aldrete score > 9.
Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.
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
Induction of anesthesia and subsequent use (or not) of the device (laryngeal mask)
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
- •age >18 years
- •written informed consent
- •elective ERCP and endoscopic ultrasound procedure
排除标准
- •pregnancy
- •contraindication to propofol administration
- •contraindication to mask insertion (e.g. malformation)
- •emergency operation (not scheduled)
- •preexisting causes of hypoventilation (e.g. chronic obstructive pulmonary disease, neuromuscular disease...)
研究组 & 干预措施
Standard Treatment
Standard Treatment Sedation with propofol target controlled infusion (TCI) and no airway devices (mandatory spontaneous breathe)
干预措施: Propofol (Drug)
Interventional Treatment
Interventional Treatment Sedation with propofol target controlled infusion (TCI) and Gastro Cuff Pilot Laryngeal Mask (possibility to use a pressure-support ventilation)
干预措施: Sedation with Gastro Cuff Pilot Laryngeal Mask (Device)
Interventional Treatment
Interventional Treatment Sedation with propofol target controlled infusion (TCI) and Gastro Cuff Pilot Laryngeal Mask (possibility to use a pressure-support ventilation)
干预措施: Propofol (Drug)
结局指标
主要结局
Partial Pressure of Carbon Dioxide (PaCO2)
时间窗: Just before patient awakening (approximately 90-120 min after induction of anesthesia)
PaCO2 level assessed by arterial sample
次要结局
- Number of pressure support ventilation in treatment group(During the procedure)
- pH(Just before patient awakening (approximately 90-120 min after induction of anesthesia))
- Partial Pressure of Oxygen (PaO2)(Just before patient awakening (approximately 90-120 min after induction of anesthesia))
- Time to recover after the procedure(During recovery room stay (approximately 15-45 min after patient awakening))
- Satisfaction of the procedure operator(1 minute after patient awakening)
- Satisfaction of the patient(20 minutes after patient awakening)
- Number of completed endoscopic procedures(During the procedure)
研究者
Agostoni Massimo
Principal Investigator
Ospedale San Raffaele