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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Endocrine Pancreas Disorder; Bile Duct Disorder

Treatments: Procedure: Endoscopic Retrograde Cholangiopancreatography; Other: Interview; Device: Laryngeal Mask Airway

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03775681

NCI-2018-03163 (Registry Identifier)

2018-0545 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Device feasibility (Laryngeal Mask Airway, ERCP)

Experimental group

Description:

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.

Treatment:

Device: Laryngeal Mask Airway

Other: Interview

Procedure: Endoscopic Retrograde Cholangiopancreatography