Clinical trial NCT03775681: Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders
Official title: Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Disorder
Endocrine Pancreas Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-12-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: The Number of Participants With Overall Success of ERCP With LMA Gastro
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
measure: Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™
timeFrame: Up to 3 months
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Katherine Hagan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hagan KB, Carlson R, Arnold B, Nguyen L, Lee J, Weston B, Hernandez M, Feng L, Syed T, Hagberg CA. Safety of the LMA(R)Gastro for Endoscopic Retrograde Cholangiopancreatography. Anesth Analg. 2020 Nov;131(5):1566-1572. doi: 10.1213/ANE.0000000000005183.