M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT03775681
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo standard of care ERCP
Other names: ERCP
Ancillary studies
Wear LMA
Other names: Laryngeal Mask; LMA
Time frame: Up to 3 months
Successful completion of ERCP with the LMA® Gastro™
Time frame: Up to 3 months
Surveys for gastroenterologist and anesthesiologist satisfaction with the Laryngeal Mask Airway (LMA) Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs.
M.D. Anderson Cancer Center
Other
Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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