Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

2018-0545


NCT ID:

NCT03775681


Secondary ID:

NCI-2018-03163


Study Acronym:


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?


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Katherine Hagan
Principal Investigator
M.D. Anderson Cancer Center

Study Dates

Start Date:January 16, 2019
Completion Date:February 2021
Completion Type:Anticipated
Primary Completion Date:February 2020
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 12, 2019
First Received Date:December 12, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Anesthesia provider satisfaction
Time Frame:Up to 3 months
Safety Issues:False
Description:Surveys for gastroenterologist and anesthesiologist satisfaction with the 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 provi
Outcome Type:Secondary Outcome
Measure:Gastroenterologist satisfaction
Time Frame:Up to 3 months
Safety Issues:False
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 deviatio
Outcome Type:Primary Outcome
Measure:Success rate
Time Frame:Up to 3 months
Safety Issues:False
Description:The success rate will be estimated using an exact 95% confidence interval. Descriptive statistics will be used to summarize all study data. Frequencies and percentages will be used to summarize the failure and success rates. Interval estimation of rates w

Study Interventions

Intervention Type:Procedure
Name:Endoscopic Retrograde Cholangiopancreatography
Description:Undergo standard of care ERCP
Arm Name:Device feasibility (Laryngeal Mask Airway, ERCP)
Other Name:ERCP
Intervention Type:Other
Name:Interview
Description:Ancillary studies
Arm Name:Device feasibility (Laryngeal Mask Airway, ERCP)
Intervention Type:Device
Name:Laryngeal Mask Airway
Description:Wear LMA
Arm Name:Device feasibility (Laryngeal Mask Airway, ERCP)
Other Name:Laryngeal Mask; LMA

Study Arms

Study Arm Type:Experimental
Arm Name:Device feasibility (Laryngeal Mask Airway, ERCP)
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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