Status:

COMPLETED

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

Lead Sponsor:

Cairo University

Collaborating Sponsors:

Theodor Bilharz Research Institute

Conditions:

Endoscopy, Gastrointestinal

Procedural Sedation

Eligibility:

All Genders

20-45 years

Phase:

NA

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 ca...

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....

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 15 2025

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07182786

Start Date

October 1 2024

End Date

July 15 2025

Last Update

September 19 2025

Active Locations (1)

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Theodor Bilharz Research Institute

Giza, Egypt, 12411