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

NCT04740164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-11-06

Study results available
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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.

Conditions

Interventions

PROCEDURE

Endoscopic Retrograde Cholangiopancreatography

Undergo ERCP with LMA Gastro

PROCEDURE

Endoscopic Retrograde Cholangiopancreatography

Undergo ERCP with standard nasal cannula

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Katherine Hagan · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2023-05-04
Completion
2023-05-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04740164 on ClinicalTrials.gov