Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03775681


Primary Contact:

Principal Investigator
Katherine Hagan
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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