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

Not Applicable

Completed

• Conditions: Gallbladder Carcinoma; Pancreatic Ductal Adenocarcinoma; Bile Duct Carcinoma
• Interventions: Procedure: Endoscopic Retrograde Cholangiopancreatography

• Registration Number: NCT04740164
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Study Start: 2021-02-24
• Primary Completion: 2023-05-04
• Study Completion: 2023-05-04
• Results First Submitted: 2024-04-23
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Results First Posted: 2024-11-06
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (ERCP with LMA Gastro)	Endoscopic Retrograde Cholangiopancreatography	Patients undergo ERCP with LMA Gastro.
Arm II (ERCP with standard nasal cannula)	Endoscopic Retrograde Cholangiopancreatography	Patients undergo ERCP with standard nasal cannula.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Had Desaturation Episodes of SpO2 <90%	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 Outcome Measures

Name	Time	Method
Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support	The time between Anesthesia Start time and Anesthesia End time	Patients in which Duodenoscope was withdrawn to facilitate airway support
Incidence of Adverse Events	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
To Evaluate Times Related to Anesthesia and Procedure	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
To Evaluate Time From Procedure End to Anesthesia End	From procedure end and anesthesia end, up to 60 minutes	The time elapsed between procedure end and anesthesia end
To Describe Heart Rates Within the Two Groups	From "anesthesia start" to "anesthesia end", on average 5 hours	Heart rates were measured prior treatment administration and at the end of the procedure.
To Describe Oxygen Saturations Within the Two Groups	From "anesthesia start" to "anesthesia end", on average 5 hours	Oxygen saturations were measured prior treatment administration and at the end of the procedure.
Incidence of Additional Airway Maneuvers	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
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups	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.
To Evaluate Anesthesiologist Placing the Device	At the end of procedure, between 5 - 10 minutes	Number of attempts means how many times the anesthesiologist tried to secure airway.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States