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

NCT06681558 | Completed

• 1 other identifier: KSH-ANREA-BG-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypoxemia; Endoscopic Retrograde Cholangiopancreatography; Airway Management; Sedation

Outcome Measures

Primary Outcomes (1)

• incidence of hypoxemia

  The incidence of hypoxemia during sedation (defined as SpO2 \< 90%). SpO₂ will be continuously measured using a pulse oximeter (GE Healthcare) to monitor and record oxygen saturation levels throughout sedation.

  Continuous SpO2 monitoring will be performed throughout the ERCP procedure

Secondary Outcomes (16)

• Number of hypoxemia episodes

  Continuous SpO2 monitoring will be performed throughout the ERCP procedure

• Duration of hypoxemia

  Continuous SpO2 monitoring will be performed throughout the ERCP procedure

• Minimum SpO2 value observed during the procedure

  Continuous SpO2 monitoring will be performed throughout the ERCP procedure

• Oxygen Reserve Index (as the baseline)

  Continuous Oxygen Reserve Index monitoring will be performed after prepreoxygenation

• Oxygen Reserve Index (immediately after the start of the procedure)

  Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure

Study Arms (2)

Group Nasal Cannula

ACTIVE COMPARATOR

Oxygen will be administered to this group via a conventional nasal cannula.

Device: Group Nasal Cannula

Group Procedural Oxygen Mask

ACTIVE COMPARATOR

Oxygen will be administered to this group via a Procedural Oxygen Mask.

Device: Group Procedural Oxygen Mask

Interventions

Group Nasal Cannula DEVICE

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.

Group Nasal Cannula

Group Procedural Oxygen Mask DEVICE

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

Group Procedural Oxygen Mask

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years
• American Society of Anesthesiologists (ASA) classification of 1-2-3
• Patients scheduled for ERCP at Kocaeli City Hospital Endoscopy Unit

You may not qualify if:

• Patients who refuse to participate in the study
• Patients with allergies to ketamine, propofol, or midazolam
• Patients diagnosed with psychiatric disorders
• Patients with a body mass index (BMI) \>30 kg/m²
• Patients with cognitive impairment, dementia, or communication issues
• Pregnant patients or those in the postpartum period
• Patients diagnosed with sleep apnea syndrome
• History of intubation within the last 3 months
• History of lower respiratory tract infection within the last 3 months
• History of intensive care unit admission within the last 3 months
• Patients with a tracheostomy
• Patients with a history of tracheostomy
• Patients who are oxygen-dependent due to a medical condition
• Patients with lung cancer or who have undergone surgery on their lungs
• Patients with asthma, COPD, or interstitial lung diseases

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, İ̇zmi̇t, 41100, Turkey (Türkiye)

Location

Related Publications (1)

• Gunel B, Sencan A, Tavsanoglu ZY, Cevik T, Atli E, Islamoglu Z, Yuksek A, Yilmaz M. Comparison of Procedural Oxygen Mask Versus Conventional Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial. Dig Dis Sci. 2025 Dec;70(12):4281-4291. doi: 10.1007/s10620-025-09264-9. Epub 2025 Jul 30.

  PMID: 40736944 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• BEDİRHAN GÜNEL, MD

  Kocaeli City Hospital

  STUDY CHAIR

• AYŞE ŞENCAN, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

• YASEMİN Y. TAVŞANOĞLU, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

• ZEKİ İSLAMOĞLU, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

• AHMET YÜKSEK, ASSOC. PROF

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

• MEHMET YILMAZ, ASSOC.PROF

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 8, 2024
• Study Start: November 12, 2024
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)