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

Not Applicable

Completed

• Conditions: Bile Duct Disorder; Endocrine Pancreas Disorder
• Interventions: Procedure: Endoscopic Retrograde Cholangiopancreatography; Other: Interview; Device: Laryngeal Mask Airway

• Registration Number: NCT03775681
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-14
• Study Start: 2019-01-16
• Primary Completion: 2020-04-20
• Study Completion: 2020-04-20
• Results First Submitted: 2021-01-13
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Results First Posted: 2021-04-27
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Adult patients undergoing elective ERCP with general anesthesia

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device feasibility (Laryngeal Mask Airway, ERCP)	Endoscopic Retrograde Cholangiopancreatography	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.
Device feasibility (Laryngeal Mask Airway, ERCP)	Interview	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.
Device feasibility (Laryngeal Mask Airway, ERCP)	Laryngeal Mask Airway	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.

Primary Outcome Measures

Name	Time	Method
The Number of Participants With Overall Success of ERCP With LMA Gastro	Up to 3 months	Successful completion of ERCP with the LMA® Gastro™

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States