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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Bile Duct Carcinoma, Gallbladder Carcinoma, Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Procedure: Endoscopic Retrograde Cholangiopancreatography
* Procedure: Endoscopic Retrograde Cholangiopancreatography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (ERCP with LMA Gastro)<br>Patients undergo ERCP with LMA Gastro. | Procedure: Endoscopic Retrograde Cholangiopancreatography<br>* Undergo ERCP with LMA Gastro<br>* Other names: ERCP;|
| Active Comparator: Arm II (ERCP with standard nasal cannula)<br>Patients undergo ERCP with standard nasal cannula. | Procedure: Endoscopic Retrograde Cholangiopancreatography<br>* Undergo ERCP with standard nasal cannula<br>* Other names: ERCP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of desaturations (oxygen saturation [SpO2] < 90%) | Defined as at any time under sedation during procedure a patient has experienced at least one episode of desaturations. Fisher's exact test will be used to compare the percentage of patients with desaturations (SpO2 < 90%) between LMA Gastro and standard nasal cannula groups. | Up to completion of endoscopic retrograde cholangiopancreatography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of additional airway maneuvers | Will be summarized through frequencies and percentages. | Up to completion of endoscopic retrograde cholangiopancreatography | 
| Incidence of adverse events | Will be summarized through frequencies and percentages. | Up to completion of endoscopic retrograde cholangiopancreatography | 
| Incidence of withdrawal of duodenoscope from airway to facilitate airway support | Will be summarized through frequencies and percentages. | Up to completion of endoscopic retrograde cholangiopancreatography |