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

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)

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Ductal Adenocarcinoma; Gallbladder Carcinoma; Bile Duct Carcinoma
• Intervention / Treatment: Procedure: Endoscopic Retrograde Cholangiopancreatography; Procedure: Endoscopic Retrograde Cholangiopancreatography

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (ERCP with LMA Gastro); Patients undergo ERCP with LMA Gastro.	Procedure: Endoscopic Retrograde Cholangiopancreatography; Undergo ERCP with LMA Gastro; Other Names: ERCP; Procedure: Endoscopic Retrograde Cholangiopancreatography; Undergo ERCP with standard nasal cannula; Other Names: ERCP
Active Comparator: Arm II (ERCP with standard nasal cannula); Patients undergo ERCP with standard nasal cannula.	Procedure: Endoscopic Retrograde Cholangiopancreatography; Undergo ERCP with LMA Gastro; Other Names: ERCP; Procedure: Endoscopic Retrograde Cholangiopancreatography; Undergo ERCP with standard nasal cannula; Other Names: ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Had Desaturation Episodes of SpO2 <90%	The desaturation (SpO2 < 90%) between patients undergoing ERCP with LMA® Gastro™ vs standard nasal cannula	The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Additional Airway Maneuvers	Number of Participants that required additional manuevers to secure airway during their surgery	The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support	Patients in which Duodenoscope was withdrawn to facilitate airway support	The time between Anesthesia Start time and Anesthesia End time
Incidence of Adverse Events	Number of adverse events reported by the participants and/or reported by care providers during Surgery and in PACU, 3 hrs in average	From PACU arrival to PACU discharge, 3 hours in average
To Evaluate Times Related to Anesthesia and Procedure	Defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively	From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutes
To Evaluate Time From Procedure End to Anesthesia End	The time elapsed between procedure end and anesthesia end	From procedure end and anesthesia end, up to 60 minutes
To Describe Heart Rates Within the Two Groups	Heart rates were measured prior treatment administration and at the end of the procedure.	From "anesthesia start" to "anesthesia end", on average 5 hours
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups	Blood pressure and end tidal carbon dioxide [CO2] were measured prior treatment administration and at the end of the procedure.	From "anesthesia start" to "anesthesia end", on average 5 hours
To Describe Oxygen Saturations Within the Two Groups	Oxygen saturations were measured prior treatment administration and at the end of the procedure.	From "anesthesia start" to "anesthesia end", on average 5 hours
To Evaluate Anesthesiologist Placing the Device	Number of attempts means how many times the anesthesiologist tried to secure airway.	At the end of procedure, between 5 - 10 minutes

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Katherine Hagan, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): May 4, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma; Carcinoma, Ductal
• Other Study ID Numbers: 2020-1014 (Other Identifier: M D Anderson Cancer Center); NCI-2021-00118 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes