Procedural Oxygen Mask vs. Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is an imaging procedure that visualizes the drainage ducts of the pancreas, gallbladder, and liver through the use of a duodenoscope and contrast media. By endoscopically identifying the ampulla of Vater, the common bile duct is cannulated. ERCP is also frequently utilized for therapeutic interventions, such as endoscopic sphincterotomy, bile duct stone extraction, stent placement in malignant and benign biliary strictures, and biopsy collection, thus playing a critical role in both the diagnosis and treatment of pancreatobiliary disorders.

ERCP, being more invasive than routine upper endoscopies or colonoscopies, typically necessitates deeper levels of sedation. The procedure is performed in the prone, modified prone, or lateral decubitus position, which increases the risk of hypoxemia and hypoventilation due to upper airway obstruction. Furthermore, endoscopic instruments inserted through the oral cavity limit anesthesiologists' access to the patient's airway, thereby restricting ventilation support during gastrointestinal endoscopy. Ensuring airway stability during sedation is paramount for patient safety and procedural efficacy. Currently, a range of devices, including traditional nasal cannulas, high-flow oxygen masks, and procedural oxygen masks, are routinely employed to provide oxygen support throughout the procedure.

The existing literature includes randomized controlled trials and systematic reviews aimed at preventing hypoxemia during ERCP. Through this study, investigators aim to make a novel contribution to the literature by assessing the effectiveness of a recently introduced procedural oxygen mask.

Conditions

• Hypoxemia

Interventions

DEVICE

Group Nasal Cannula

Oxygen administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure will be delivered through a conventional oxygen mask. The nasal cannula is a device that provides oxygen to patients through the nasal passages.

DEVICE

Group Procedural Oxygen Mask

Oxygen administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure will be delivered through a Procedural Oxygen Mask (POM® ELITE MF). The procedural oxygen mask is a device that covers both the mouth and nose to deliver oxygen to the patient. Its reservoir feature increases the concentration of delivered oxygen

Sponsors & Collaborators

• Kocaeli City Hospital

  lead OTHER_GOV

Principal Investigators

• BEDİRHAN GÜNEL, MD · Kocaeli City Hospital

• AYŞE ŞENCAN, MD · Kocaeli City Hospital

• YASEMİN Y. TAVŞANOĞLU, MD · Kocaeli City Hospital

• ZEKİ İSLAMOĞLU, MD · Kocaeli City Hospital

• AHMET YÜKSEK, ASSOC. PROF · Kocaeli City Hospital

• MEHMET YILMAZ, ASSOC.PROF · Kocaeli City Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-12

Primary Completion

2025-02-06

Completion

2025-02-06

Countries

• Turkey (Türkiye)

Study Locations