The Efficacy of Laryngeal Mask Airway Gastro (LMA® Gastro™) in Preventing Hypercarbia in ERCP Patients

NCT ID: NCT07182786

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-07-15

Brief Summary

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.

Detailed Description

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.

Although the LMA Gastro has been demonstrated in several studies as a safe and efficient substitute for general anesthesia or deep sedation tubeless anesthesia for ERCP procedures, to date there is no exact measurement or assessment of its role in prevention of hypercarbia or hypoxia.

Aim of the work:

The aim of this study is to evaluate the efficacy of using LMA Gastro in preventing hypercarbia and decreasing hypoxic and hyper carbic episodes in patients undergoing ERCP procedures of average timing and difficulty according to the ASGE (American Society of Gastroenterologists) grading system. In addition, to assess the efficiency of using the new LMA Gastro® airway device in endoscopic procedures and its stress response.

Conditions

Endoscopy, Gastrointestinal; Procedural Sedation; Anesthesia Airway Management; Anesthesia for Endoscopic Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

LMA Gastro group (L group): total intravenous anesthesia and LMA Gastro

Group Type: ACTIVE_COMPARATOR

LMA Gastro

Intervention Type: DEVICE

LMA Gastro, is a laryngeal mask airway device that is specifically designed for air way management in GIT endoscopic procedures due to having a channel dedicated for endoscope introduction. the safety and efficacy of LMA Gastro was researched in many studies, but its role in preventing Hypercarbia during ERCP procedures is yet to be researched and tested.

Control group (C group): total intravenous anesthesia with no airway device , with Nasal Cannula.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LMA Gastro

LMA Gastro, is a laryngeal mask airway device that is specifically designed for air way management in GIT endoscopic procedures due to having a channel dedicated for endoscope introduction. the safety and efficacy of LMA Gastro was researched in many studies, but its role in preventing Hypercarbia during ERCP procedures is yet to be researched and tested.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Karim Mohamed Aly Ahmed

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Theodor Bilharz Research Institute

Giza, , Egypt

Countries

Egypt

Other Identifiers

MD-507-2023

Identifier Type: -

Identifier Source: org_study_id