Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03775681 |
Other study ID # |
2018-0545 |
Secondary ID |
NCI-2018-0316320 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 16, 2019 |
Est. completion date |
April 20, 2020 |
Study information
Verified date |
March 2021 |
Source |
M.D. Anderson Cancer Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.