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A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP

Primary Purpose

Bile Duct Carcinoma, Gallbladder Carcinoma, Pancreatic Ductal Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Retrograde Cholangiopancreatography
Endoscopic Retrograde Cholangiopancreatography
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bile Duct Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (>= 18 years old) undergoing ERCP

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
  • Patient with known difficult airway requiring advanced intubation equipment (with the exception of the video-laryngoscope) in the past
  • 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
  • Patients with hypoxemia (SpO2 < 94% on room air or on home oxygen)
  • American Society of Anesthesiology (ASA) Physical Status IV-V

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (ERCP with LMA Gastro)

Arm II (ERCP with standard nasal cannula)

Arm Description

Patients undergo ERCP with LMA Gastro.

Patients undergo ERCP with standard nasal cannula.

Outcomes

Primary Outcome Measures

Incidence of desaturations (oxygen saturation [SpO2] < 90%)
Defined as at any time under sedation during procedure a patient has experienced at least one episode of desaturations. Fisher's exact test will be used to compare the percentage of patients with desaturations (SpO2 < 90%) between LMA Gastro and standard nasal cannula groups.

Secondary Outcome Measures

Incidence of additional airway maneuvers
Will be summarized through frequencies and percentages.
Incidence of adverse events
Will be summarized through frequencies and percentages.
Incidence of withdrawal of duodenoscope from airway to facilitate airway support
Will be summarized through frequencies and percentages.

Full Information

First Posted
January 29, 2021
Last Updated
August 30, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04740164
Brief Title
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
Official Title
A Randomized Study to Compare LMA® Gastro™, a Dual Channel Supraglottic Airway (SGA) Device, to Oxygenation With Standard Nasal Cannula for Endoscopic Retrograde Cholangiopancreatography (ERCP)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
May 4, 2023 (Actual)
Study Completion Date
May 4, 2023 (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
Yes

5. Study Description

Brief Summary
This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.
Detailed Description
PRIMARY OBJECTIVE: I. To compare the incidence of desaturation (oxygen saturation [SpO2] < 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula. SECONDARY OBJECTIVES: I. To evaluate the incidence of additional airway maneuvers (jaw thrust/chin lift/placement of oral airway or/nasal trumpet/intubation). II. To evaluate the incidence of withdrawal of duodenoscope from the airway to facilitate airway support. III. To evaluate the incidence of adverse events. IV. To evaluate times related to anesthesia and procedure (defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively). V. To evaluate time from procedure end to anesthesia end. VI. To describe hemodynamics within the two groups (recorded blood pressures, heart rates, oxygen saturations, and end tidal carbon dioxide [CO2]). VII. To evaluate anesthesiologist placing the device (training video viewed, number of practice attempts, years of experience). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo ERCP with LMA Gastro. ARM II: Patients undergo ERCP with standard nasal cannula.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Carcinoma, Gallbladder Carcinoma, Pancreatic Ductal Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (ERCP with LMA Gastro)
Arm Type
Experimental
Arm Description
Patients undergo ERCP with LMA Gastro.
Arm Title
Arm II (ERCP with standard nasal cannula)
Arm Type
Active Comparator
Arm Description
Patients undergo ERCP with standard nasal cannula.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Retrograde Cholangiopancreatography
Other Intervention Name(s)
ERCP
Intervention Description
Undergo ERCP with LMA Gastro
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Retrograde Cholangiopancreatography
Other Intervention Name(s)
ERCP
Intervention Description
Undergo ERCP with standard nasal cannula
Primary Outcome Measure Information:
Title
Incidence of desaturations (oxygen saturation [SpO2] < 90%)
Description
Defined as at any time under sedation during procedure a patient has experienced at least one episode of desaturations. Fisher's exact test will be used to compare the percentage of patients with desaturations (SpO2 < 90%) between LMA Gastro and standard nasal cannula groups.
Time Frame
Up to completion of endoscopic retrograde cholangiopancreatography
Secondary Outcome Measure Information:
Title
Incidence of additional airway maneuvers
Description
Will be summarized through frequencies and percentages.
Time Frame
Up to completion of endoscopic retrograde cholangiopancreatography
Title
Incidence of adverse events
Description
Will be summarized through frequencies and percentages.
Time Frame
Up to completion of endoscopic retrograde cholangiopancreatography
Title
Incidence of withdrawal of duodenoscope from airway to facilitate airway support
Description
Will be summarized through frequencies and percentages.
Time Frame
Up to completion of endoscopic retrograde cholangiopancreatography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (>= 18 years old) undergoing ERCP 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 Patient with known difficult airway requiring advanced intubation equipment (with the exception of the video-laryngoscope) in the past 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 Patients with hypoxemia (SpO2 < 94% on room air or on home oxygen) American Society of Anesthesiology (ASA) Physical Status IV-V
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

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP

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