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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.


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

Study Design


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
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