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临床试验/NCT04831489
NCT04831489Unknown不适用

Risk of Pulmonary Micro-aspiration in Intubated vs Sedated Patients Undergoing ERCP

Theodor Bilharz Research Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
POPA

研究概览

简要总结

Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge. apparent aspiration is noticeable however microaspiration is hard to detect clinically. our study aims at determining whether general anesthesia with endotracheal intubation or deep sedation is safer in ERCP patients.

详细描述

Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. In fact, with the wide use of ERCP, many critical patients in whom conventional surgery was a high-risk procedure could be managed by endoscopic treatment.

Compared to other endoscopic procedures, ERCP is considered a relatively longer and more complex one, with a substantially higher complication rate. Anesthetic techniques must facilitate the success of this procedure without adding to morbidity.

Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge.

Many anesthetic techniques are used, ranging from conscious sedation to general anesthesia. The worldwide accepted method is deep sedation in the presence of an anesthetist without endotracheal intubation. Intubation is recommended in very exceptional cases, for example is morbidly obese patients.

According to some authors, general anesthesia is less used as an anesthetic technique in ERCP; drawbacks of GA include: the lengthier time required for induction of and recovery from anesthesia which affects patients' turnover, the risk of residual neuromuscular blockade, the higher cost as well as ERCP is usually a day case procedure favoring the sedation technique. On the other hand, monitored anesthesia care or deep sedation in remote locations can avoid these drawbacks.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 years old.
  • Preoperative pulmonary stability criteria (defined as a respiratory rate 12-24 breaths per minute, SpO2 ≥ 94% on room air) -

排除标准

  • Age < 18 years.
  • Morbid obesity BMI ≥ 40 Kg/ m
  • Fasting ≤ 6 hours for solid food and ≤ 2 hours for clear liquids. 4
  • A pre-existing lung condition in patients requiring supplemental oxygen, inhalational bronchodilator, or systemic bronchodilator or steroid.
  • Patients in the intensive care unit and/or requiring mechanical ventilation prior to the procedure.
  • Previously intubated patients during the same hospitalization.
  • Tracheostomized patients.
  • Patients with swallowing disorders.
  • Bowel obstruction.
  • Anticipated difficult intubation.

结局指标

主要结局

POPA

时间窗: 24 hours postoperatively

Perioperative Pulmonary Aspiration (POPA), which will be defined as the presence of an acute pulmonary infiltrate on chest CT within the 24 hours period following ERCP.

次要结局

  • Number of intraoperative hypoxic episodes.(24 hours postoperative.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moshira sayed mohamed

Lecturer of Anasthesia and intensive care

Theodor Bilharz Research Institute

研究点 (1)

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