Clinical trial NCT04740164: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Carcinoma
Gallbladder Carcinoma
Pancreatic Ductal Adenocarcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants That Had Desaturation Episodes of SpO2 <90%
timeFrame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
Secondary outcomes:
measure: Incidence of Additional Airway Maneuvers
timeFrame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
measure: Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support
timeFrame: The time between Anesthesia Start time and Anesthesia End time
measure: Incidence of Adverse Events
timeFrame: From PACU arrival to PACU discharge, 3 hours in average
measure: To Evaluate Times Related to Anesthesia and Procedure
timeFrame: From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutes
measure: To Evaluate Time From Procedure End to Anesthesia End
timeFrame: From procedure end and anesthesia end, up to 60 minutes
measure: To Describe Heart Rates Within the Two Groups
timeFrame: From "anesthesia start" to "anesthesia end", on average 5 hours
measure: To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
timeFrame: From "anesthesia start" to "anesthesia end", on average 5 hours
measure: To Describe Oxygen Saturations Within the Two Groups
timeFrame: From "anesthesia start" to "anesthesia end", on average 5 hours
measure: To Evaluate Anesthesiologist Placing the Device
timeFrame: At the end of procedure, between 5 - 10 minutes
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Katherine Hagan
role: PRINCIPAL_INVESTIGATOR
References: