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

NCT04740164 | Completed Results DMC FDA Device

• 2 other identifiers: 2020-1014NCI-2021-00118
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Duct Carcinoma; Gallbladder Carcinoma; Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of Additional Airway Maneuvers

  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

  The time between Anesthesia Start time and Anesthesia End time

• Incidence of Adverse Events

  From PACU arrival to PACU discharge, 3 hours 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

• To Evaluate Time From Procedure End to Anesthesia End

  From procedure end and anesthesia end, up to 60 minutes

Study Arms (2)

Arm I (ERCP with LMA Gastro)

EXPERIMENTAL

Patients undergo ERCP with LMA Gastro.

Procedure: Endoscopic Retrograde Cholangiopancreatography

Arm II (ERCP with standard nasal cannula)

ACTIVE COMPARATOR

Patients undergo ERCP with standard nasal cannula.

Procedure: Endoscopic Retrograde Cholangiopancreatography

Interventions

Endoscopic Retrograde Cholangiopancreatography PROCEDURE

Undergo ERCP with LMA Gastro

Also known as: ERCP

Arm I (ERCP with LMA Gastro)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Katherine Hagan
• Organization: The University of Texas MD Anderson Cancer Center

khagan@mdanderson.org

(713) 794-5945

Study Officials

• Katherine Hagan

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 5, 2021
• Study Start: February 24, 2021
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: November 6, 2024
• Results First Posted: November 6, 2024

Record last verified: 2024-11

Locations

US (1)