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

Study Overview
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Brief Summary
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This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients breathe while they are asleep during procedures.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the successful completion of endoscopic retrograde cholangiopancreatography (ERCP) with the Laryngeal Mask Airway (LMA) Gastro. SECONDARY OBJECTIVES: I. To determine gastroenterologist satisfaction with the LMA Gastro. II. To determine anesthesia provider satisfaction with the LMA Gastro. III. To determine the rate of unsuccessful LMA Gastro placement. IV. To determine the ability of LMA Gastro to provide adequate oxygenation and ventilation throughout the procedure. V. To determine and describe the rate of adverse events. OUTLINE: Patients wear Laryngeal Mask Airway Gastro after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.

Official Title
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Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?

Conditions
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Bile Duct Disorder, Endocrine Pancreas Disorder

Intervention / Treatment
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* Procedure: Endoscopic Retrograde Cholangiopancreatography
* Other: Interview
* Device: Laryngeal Mask Airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing elective ERCP with general anesthesia 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 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 Non-English speaking patients

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device feasibility (Laryngeal Mask Airway, ERCP)<br>Patients wear Laryngeal Mask Airway after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure. | Procedure: Endoscopic Retrograde Cholangiopancreatography<br>* Undergo standard of care ERCP<br>* Other names: ERCP;Other: Interview<br>* Ancillary studies<br>Device: Laryngeal Mask Airway<br>* Wear LMA<br>* Other names: Laryngeal Mask; LMA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Overall Success of ERCP With LMA Gastro | Successful completion of ERCP with the LMA® Gastro™ | Up to 3 months |