NCT07182786

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

Completed NA Last updated 19 September 2025

What this trial tests

NA trial testing LMA Gastro in Endoscopy, Gastrointestinal in 50 participants. Completed in 15 July 2025.

Timeline

1 October 2024

Primary endpoint
15 July 2025

15 July 2025

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	50
Start date	1 October 2024
Primary completion	15 July 2025
Estimated completion	15 July 2025
Sites	1 location across Egypt

Drugs / interventions tested

• LMA Gastro

Conditions studied

• Endoscopy, Gastrointestinal — all drugs for Endoscopy, Gastrointestinal →
• Procedural Sedation — all drugs for Procedural Sedation →
• Anesthesia Airway Management — all drugs for Anesthesia Airway Management →
• Anesthesia for Endoscopic Procedures — all drugs for Anesthesia for Endoscopic Procedures →

Sponsor

Cairo University

Who can join

Adults 20 to 45, any sex, with Endoscopy, Gastrointestinal or Procedural Sedation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.