Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders

Endocrine Pancreas Disorder Clinical Trial

Official title:

Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?

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
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Bile Duct Disorder
• Disease
• Endocrine Pancreas Disorder

Intervention

Procedure:
• Endoscopic Retrograde Cholangiopancreatography
Undergo standard of care ERCP

Other:
• Interview
Ancillary studies

Device:
• Laryngeal Mask Airway
Wear LMA

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™	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.	Up to 3 months
Primary	The Number of Participants With Overall Success of ERCP With LMA Gastro	Successful completion of ERCP with the LMA® Gastro™	Up to 3 months

External Links

•   MD Anderson Cancer Center Website