跳至主要内容
临床试验/NCT07182786
NCT07182786已完成不适用

The Efficacy of Laryngeal Mask Airway Gastro (LMA® Gastro™) in Preventing Hypercarbia in ERCP Patients: A Randomized Controlled Study

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
End tidal CO2

研究概览

简要总结

Endoscopic retrograde cholangiopancreatography (ERCP) has evolved into a primarily therapeutic procedure that often requires anesthetic support. While moderate to deep sedation is commonly used, it carries a high risk of respiratory complications, including hypoxemia and hypercapnia, which can lead to cardiovascular instability. General anesthesia with endotracheal intubation offers greater airway protection but is associated with hemodynamic stress, the need for neuromuscular blockade, longer recovery, and potential airway trauma.

The LMA® Gastro™ Airway, introduced in 2017, was specifically designed for upper gastrointestinal endoscopy. It combines a supraglottic airway with a dedicated channel for the endoscope, enabling ventilation and airway protection while facilitating the procedure. Early studies demonstrate high success rates for both airway management and ERCP completion, with a low incidence of adverse events. However, most available evidence is observational, and randomized controlled trials are needed to establish its effectiveness compared with traditional sedation and general anesthesia with intubation.

In conclusion, the LMA Gastro shows promise as a safe and efficient alternative airway device for ERCP, potentially bridging the gap between deep sedation and invasive intubation, though further evidence is required to confirm its impact on respiratory and hemodynamic outcomes.

详细描述

Endoscopic retrograde cholangiopancreatography (ERCP) is fast emerging as a therapeutic procedure rather than a diagnostic one, requiring anesthetic support for successful completion of the procedure. The procedure can be uncomfortable especially due to prone positioning, multiple passages of endoscope, air insufflations, dilatation of ductal structures and prolonged duration which requires a high degree of cooperation from patients. A large number of patients need to be given general anesthesia (GA), in order to minimize incidence of adverse respiratory and hemodynamic events in the peri-procedure period. The use of GA with endotracheal intubation (ETT) or supraglottic devices protects the airway, reduces ERCP failure and complication rates. However, ETT involves rigid laryngoscopy with consequent undesirable hemodynamic responses and use of neuromuscular blocking drugs. It also has the disadvantage of a longer recovery time and possibility of injury to the oro-pharynx at insertion.

Moderate to deep sedation is a commonly employed technique for ERCPs, with general anesthesia utilizing an endotracheal intubation being reserved for selected cases. Reported rates of hypoxemia during all endoscopic procedures range from 11 to 50%, and this may be as high as 60% with ERCP. Sustained hypoxia is a major risk factor for peri-procedural cardiac arrhythmias and myocardial ischemia. Respiratory complications that occur during intravenous sedation have a higher risk of hypercapnia than hypoxemia. Patients receiving propofol-based tubeless sedation may be at higher risk of sedation-related adverse events than patients receiving GA. Moreover, when low-flow oxygen is administered through a nasal cannula, the apparent oxygen saturation value is maintained at a normal concentration; however, hypoventilation is sustained, which may result in impaired exhalation. Gradual CO₂ accumulation, and CO₂ concentrations maintained at 60 mmHg or higher, are risk factors for secondary circulatory abnormalities such as an abnormal increase in blood pressure, tachycardia, and arrhythmia.

As the number of gastrointestinal endoscopic interventions and possibilities increased, and the number of patients with severe comorbidities and existing medical conditions, the need for minimally invasive airway devices specially dedicated for endoscopic procedures became relevant. A modified laryngeal tube with a dedicated channel for an endoscope was described as an alternative airway device. This approach was further developed with the introduction of the LMA® Gastro™ Airway, a refined tool in advanced airway management for upper gastrointestinal endoscopy.

The LMA® Gastro™ Airway is a cuffed peri-laryngeal supraglottic airway (SGA) with an endoscopic channel, having a maximum diameter of 14 mm, which suits all standard endoscopes. Its design features include a channel for esophageal intubation, a separate channel with a terminal cuff for lung ventilation, and an integrated bite block and cuff pressure indicator. It comes in three available sizes: #3 (30-50 kg), #4 (50-70 kg), and #5 (70-100 kg).

This device has been reported to have a high airway insertion success rate and a high first-attempt endoscopy success rate in patients with low risk of pulmonary aspiration. Observational studies have suggested that the LMA Gastro may be a safe alternative to tubeless anesthesia in patients undergoing ERCP, though some were limited by small sample size and non-randomized design. Retrospective analyses have demonstrated high success rates of ERCP completion with well-maintained ventilation and minimal intraoperative and postoperative adverse events. However, confounding factors in patient selection and the absence of randomized controlled comparisons with conventional airway techniques remain limitations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients age: 20-45 years
  • ASA classification: II and III
  • Body mass index: 25 -30 kg/m2
  • Height > 155 cm
  • ERCP procedures of difficulty grade II and III (according to American Society of Gastroenterologists ASGE grading system for ERCP procedures).

排除标准

  • Anticipated difficult airway
  • Restricted head and neck mobility
  • Pulmonary disease
  • Obese Patients with a BMI of ≥ 35 kg/m2
  • Patients with moderate to severe ascites
  • Patients with Childe-Pughe-Turcotte (CPT) classification C
  • Increased risk of aspiration (for example incomplete fasting hours, delayed gastric emptying, gastric outlet obstruction, etc.)
  • ERCP procedures of difficulty grade I (due to relatively short procedure duration)
  • ERCP procedures of malignant obstructive jaundice
  • ERCP procedures less than 30 minutes and more than 120 minutes.
  • Patient refusal

结局指标

主要结局

End tidal CO2

时间窗: 30 minutes from induction of Anesthesia

End tidal CO2 measurement after 30 minutes of procedure time. It is measured by capnography in patients undergoing ERCP procedure.

次要结局

  • Hypercarbia(Procedures of duration between 30 and 120 minutes)
  • Timing of Hypercarbia(Procedures of duration between 30 and 120 minutes)
  • Hypoxia(Procedures of duration between 30 and 120 minutes.)
  • Number of Hypoxic episodes(Procedures of duration between 30 and 120 minutes)
  • Hemodynamic stress response : Heart Rate(Procedures of duration between 30 and 120 minutes.)
  • Hemodynamic stress response : Mean arterial blood pressure(Procedures of duration between 30 and 120 minutes.)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: duration till endoscope introduction.(From Anesthesia induction till start of procedure)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: Ease of duodenoscope introduction.(From induction of Anesthesia till start of procedure)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: ease of LMA Gastro insertion.(From induction of Anesthesia till start of procedure)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: Safety of LMA Gastro(During whole ERCP procedure)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: Anesthetic consumption of propofol(whole duration of ERCP procedure)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: Recovery time(from the end of ERCP procedure till discharge to PACU)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: procedure failure(procedures between 30 and 120 minutes)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: procedure duration(procedures between 30 and 120 minutes)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: post operative complications(From end of procedure till discharge from PACU (after 30 min.))
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: operator satisfaction(procedures between 30 and 120 minutes)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: anesthesiologist satisfaction(procedures between 30 and 120 minutes)
  • Efficiency of LMA gastro in anesthesia of ERCP procedures: conversion to endotracheal intubation.(procedures between 30 and 120 minutes)

研究者

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

Karim Mohamed Aly Ahmed

Assistant Lecturer of Anesthesiology, Surgical ICU & Pain Management,Theodor Bilharz Research Institute. Candidate for MD degree , Anaesthesia department , Cairo University.

Theodor Bilharz Research Institute

研究点 (2)

Loading locations...

相似试验

The Efficacy of Laryngeal Mask Airway Gastro (LMA®... | 临床试验