Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders
Primary Purpose
Bile Duct Disorder, Endocrine Pancreas Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Retrograde Cholangiopancreatography
Interview
Laryngeal Mask Airway
Sponsored by
About this trial
This is an interventional supportive care trial for Bile Duct Disorder
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device feasibility (Laryngeal Mask Airway, ERCP)
Arm Description
Patients wear Laryngeal Mask Airway 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.
Outcomes
Primary Outcome Measures
The Number of Participants With Overall Success of ERCP With LMA Gastro
Successful completion of ERCP with the LMA® Gastro™
Secondary Outcome Measures
Full Information
NCT ID
NCT03775681
First Posted
December 12, 2018
Last Updated
March 31, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03775681
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Disorder, Endocrine Pancreas Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device feasibility (Laryngeal Mask Airway, ERCP)
Arm Type
Experimental
Arm Description
Patients wear Laryngeal Mask Airway 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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Retrograde Cholangiopancreatography
Other Intervention Name(s)
ERCP
Intervention Description
Undergo standard of care ERCP
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Ancillary studies
Intervention Type
Device
Intervention Name(s)
Laryngeal Mask Airway
Other Intervention Name(s)
Laryngeal Mask; LMA
Intervention Description
Wear LMA
Primary Outcome Measure Information:
Title
The Number of Participants With Overall Success of ERCP With LMA Gastro
Description
Successful completion of ERCP with the LMA® Gastro™
Time Frame
Up to 3 months
Other Pre-specified Outcome Measures:
Title
Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™
Description
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.
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Hagan
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33079880
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.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders
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