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OpenTrials
Completed

NCT Number: NCT03775681

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic retrograde cholangiopancreatography

Procedure

Undergo standard of care ERCP

Other names: ERCP

interview

Other

Ancillary studies

Laryngeal mask airway

Device

Wear LMA

Other names: Laryngeal Mask; LMA

Primary outcomes

  1. The Number of Participants With Overall Success of ERCP With LMA Gastro

    Time frame: Up to 3 months

    Successful completion of ERCP with the LMA® Gastro™

Other outcomes

  1. Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™

    Time frame: Up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2018
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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