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

NCT07182786 | Completed FDA Device

• 1 other identifier: MD-507-2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ERCP anesthesia; Anesthesia for endoscopy; LMA Gastro; Hypercarbia

Outcome Measures

Primary Outcomes (1)

• End tidal CO2

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

  30 minutes from induction of Anesthesia

Secondary Outcomes (18)

• 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.

Study Arms (2)

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

ACTIVE COMPARATOR

Device: LMA Gastro

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

NO INTERVENTION

Interventions

LMA Gastro 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.

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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Theodor Bilharz Research Institute: collaborator

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 12411, Egypt

Location

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical ICU & Pain Management,Theodor Bilharz Research Institute. Candidate for MD degree , Anaesthesia department , Cairo University.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

EG (1)