NCT04740164

A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP

A Randomized Study to Compare LMA® Gastro™, a Dual Channel Supraglottic Airway (SGA) Device, to Oxygenation With Standard Nasal Cannula for Endoscopic Retrograde Cholangiopancreatography (ERCP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.

Detailed description

PRIMARY OBJECTIVE: I. To compare the incidence of desaturation (oxygen saturation \[SpO2\] \< 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula. SECONDARY OBJECTIVES: I. To evaluate the incidence of additional airway maneuvers (jaw thrust/chin lift/placement of oral airway or/nasal trumpet/intubation). II. To evaluate the incidence of withdrawal of duodenoscope from the airway to facilitate airway support. III. To evaluate the incidence of adverse events. IV. To evaluate times related to anesthesia and procedure (defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively). V. To evaluate time from procedure end to anesthesia end. VI. To describe hemodynamics within the two groups (recorded blood pressures, heart rates, oxygen saturations, and end tidal carbon dioxide \[CO2\]). VII. To evaluate anesthesiologist placing the device (training video viewed, number of practice attempts, years of experience). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo ERCP with LMA Gastro. ARM II: Patients undergo ERCP with standard nasal cannula.

Conditions

• Bile Duct Carcinoma
• Gallbladder Carcinoma
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Retrograde Cholangiopancreatography	Undergo ERCP with LMA Gastro
PROCEDURE	Endoscopic Retrograde Cholangiopancreatography	Undergo ERCP with standard nasal cannula

Timeline

• Start date: 2021-02-24
• Primary completion: 2023-05-04
• Completion: 2023-05-04
• First posted: 2021-02-05
• Last updated: 2024-11-06
• Results posted: 2024-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study