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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2023-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders

NCT03775681

Bile Duct Disorder Endocrine Pancreas Disorder

COMPLETED NA

Procedural Oxygen Mask vs. High-flow Nasal Cannula for Hypoxemia Prevention During ERCP

NCT06817603

Hypoxemia

COMPLETED NA

Procedural Oxygen Mask vs. Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography

NCT06681558

Hypoxemia

COMPLETED NA

Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation

NCT02197338

Cholestasis, Extrahepatic

COMPLETED NA

Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy

NCT02543957

Cholangitis Bacteremia

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bile Duct Carcinoma Gallbladder Carcinoma Pancreatic Ductal Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (ERCP with LMA Gastro)

Patients undergo ERCP with LMA Gastro.

Group Type EXPERIMENTAL

Endoscopic Retrograde Cholangiopancreatography

Intervention Type PROCEDURE

Undergo ERCP with LMA Gastro

Arm II (ERCP with standard nasal cannula)

Patients undergo ERCP with standard nasal cannula.

Group Type ACTIVE_COMPARATOR

Endoscopic Retrograde Cholangiopancreatography

Intervention Type PROCEDURE

Undergo ERCP with standard nasal cannula

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic Retrograde Cholangiopancreatography

Undergo ERCP with LMA Gastro

Intervention Type PROCEDURE

Endoscopic Retrograde Cholangiopancreatography

Undergo ERCP with standard nasal cannula

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ERCP ERCP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (\>= 18 years old) undergoing ERCP

Exclusion Criteria

* Patients with propofol allergy
* Patients at increased aspiration risk
* Patients with abnormal head/neck pathology preventing LMA Gastro placement
* Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
* Patient with known difficult airway requiring advanced intubation equipment (with the exception of the video-laryngoscope) in the past
* Esophagectomy patients
* Patients already intubated upon arrival to endoscopy suite
* Patients undergoing endoscopic ultrasound (EUS)
* Patients with body mass index (BMI) \>= 35 kg/m\^2
* Patients with hypoxemia (SpO2 \< 94% on room air or on home oxygen)
* American Society of Anesthesiology (ASA) Physical Status IV-V

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No