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NCT Number: NCT04740164

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

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Key information

Conditions

Bile Duct Carcinoma Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Gallbladder Carcinoma Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Site Pancreatic Ductal Adenocarcinoma

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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Endoscopic retrograde cholangiopancreatography

Procedure

Undergo ERCP with LMA Gastro

Other names: ERCP

Primary outcomes

  1. Number of Participants That Had Desaturation Episodes of SpO2 <90%

    Time frame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average

    The desaturation (SpO2 < 90%) between patients undergoing ERCP with LMA® Gastro™ vs standard nasal cannula

Secondary outcomes

  1. Incidence of Additional Airway Maneuvers

    Time frame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average

    Number of Participants that required additional manuevers to secure airway during their surgery

  2. Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support

    Time frame: The time between Anesthesia Start time and Anesthesia End time

    Patients in which Duodenoscope was withdrawn to facilitate airway support

  3. Incidence of Adverse Events

    Time frame: From PACU arrival to PACU discharge, 3 hours in average

    Number of adverse events reported by the participants and/or reported by care providers during Surgery and in PACU, 3 hrs in average

  4. To Evaluate Times Related to Anesthesia and Procedure

    Time frame: From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutes

    Defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively

  5. To Evaluate Time From Procedure End to Anesthesia End

    Time frame: From procedure end and anesthesia end, up to 60 minutes

    The time elapsed between procedure end and anesthesia end

  6. To Describe Heart Rates Within the Two Groups

    Time frame: From "anesthesia start" to "anesthesia end", on average 5 hours

    Heart rates were measured prior treatment administration and at the end of the procedure.

  7. To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups

    Time frame: From "anesthesia start" to "anesthesia end", on average 5 hours

    Blood pressure and end tidal carbon dioxide [CO2] were measured prior treatment administration and at the end of the procedure.

  8. To Describe Oxygen Saturations Within the Two Groups

    Time frame: From "anesthesia start" to "anesthesia end", on average 5 hours

    Oxygen saturations were measured prior treatment administration and at the end of the procedure.

  9. To Evaluate Anesthesiologist Placing the Device

    Time frame: At the end of procedure, between 5 - 10 minutes

    Number of attempts means how many times the anesthesiologist tried to secure airway.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2021
Registry last updated
Nov 6, 2024

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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