Procedural Oxygen Mask vs. High-flow Nasal Cannula for Hypoxemia Prevention During ERCP

NCT06817603 | Completed

• 1 other identifier: KSH-ANREA-BG-05
• 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 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

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 (12)

• 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

• Continuous SpO2 monitoring will be performed throughout the ERCP procedure

  Continuous SpO2 monitoring will be performed throughout the ERCP procedure

• Frequency of Chin Lift Maneuver

  Interventions related to airway management causing interruptions during the procedure

• Frequency of Jaw Thrust Maneuver

  Interventions related to airway management causing interruptions during the procedure

Study Arms (2)

Group P

ACTIVE COMPARATOR

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

Device: Procedural Oxygen Mask

Group H

ACTIVE COMPARATOR

During the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, oxygen will be delivered through a High-Flow Nasal Cannula (HFNC) device. The high-flow nasal cannula is a device that provides humidified and heated oxygen to the patient via the nasal route. Its high flow rate increases the fraction of inspired oxygen (FiO₂), ensuring more effective oxygenation and reducing dead space ventilation.

Device: High-Flow Nasal Cannula

Interventions

Procedural Oxygen Mask DEVICE

Procedural Oxygen Mask will be used

Group P

High-Flow Nasal Cannula DEVICE

High-Flow Nasal Cannula (HFNC) will be used.

Group H

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:

• Refused to participate in the study
• Had an allergy to ketamine, propofol, or midazolam
• Had a BMI \>30 kg/m²
• Were pregnant or in the postpartum period
• Had a STOP-BANG score ≥3
• Had a history of intubation within the past 3 months
• Had a history of lower respiratory tract infection within the past 3 months
• Had a history of intensive care unit (ICU) admission within the past 3 months
• Had a tracheostomy or a history of tracheostomy placement
• Were oxygen-dependent
• Had lung cancer or a history of lung surgery
• Had asthma, COPD, or interstitial lung disease

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, İ̇zmi̇t, 41100, Turkey (Türkiye)

Location

Related Publications (1)

• Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.

  PMID: 33933271 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

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: January 31, 2025
• First Posted: February 10, 2025
• Study Start: March 7, 2025
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)