Status:

COMPLETED

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

Lead Sponsor:

M.D. Anderson Cancer Center

Conditions:

Bile Duct Carcinoma

Gallbladder Carcinoma

Eligibility:

All Genders

18+ years

Phase:

NA

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 (E...

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 OBJE...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

February 24 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 4 2023

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT04740164

Start Date

February 24 2021

End Date

May 4 2023

Last Update

November 6 2024

Active Locations (1)

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1

M D Anderson Cancer Center

Houston, Texas, United States, 77030