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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:January 16, 2019
End Date:June 30, 2019
Contact:Katherine Hagan
Email:khagan@mdanderson.org
Phone:713-563-0034

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

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.

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.

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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Katherine Hagan
Phone: 713-563-0034
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Houston, TX
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