High-Flow Nasal Oxygen During Endoscopic Retrograde Cholangiopancreatography In Geriatric Patients (HFNO ERCP)

High-Flow Nasal Oxygen Versus Conventional Oxygen Therapy During Sedated ERCP In Geriatric And Adult Patients: A Randomized Controlled Trial

This prospective, single-centre, randomized controlled trial evaluates whether high-flow nasal oxygen (HFNO) reduces hypoxaemia compared with conventional low-flow oxygen therapy (COT) during endoscopic retrograde cholangiopancreatography (ERCP) performed under sedation in geriatric and adult patients.

One hundred ASA I-III patients undergoing ERCP were stratified by age (<65 and ≥65 years) and randomized to receive HFNO or COT. The primary outcome is the incidence of hypoxaemia (SpO₂ ≤90%). Secondary outcomes include hypotension, haemodynamic changes, sedative consumption, and recovery time.

Study Overview

• Status: Completed
• Conditions: Hypoxemia; Hemodynamic Instability
• Intervention / Treatment: Device: HFNO; Device: Conventional Oxygen Therapy

Detailed Description

Endoscopic retrograde cholangiopancreatography (ERCP) is a complex gastrointestinal endoscopic procedure frequently performed under deep sedation. Due to the prone position, prolonged procedural duration, and sedative-induced respiratory depression, ERCP is associated with an increased risk of cardiopulmonary complications, particularly hypoxaemia and haemodynamic instability. These risks are more pronounced in geriatric patients because of age-related reductions in respiratory reserve, impaired ventilatory response to hypercapnia, and diminished cardiovascular compensatory mechanisms.

Conventional oxygen therapy (COT) delivered via low-flow nasal cannula is routinely used during sedated ERCP. However, low-flow systems may provide inconsistent inspired oxygen concentrations and do not generate positive airway pressure. High-flow nasal oxygen (HFNO) delivers heated and humidified oxygen at high flow rates, allowing for stable fractional inspired oxygen (FiO₂) delivery, nasopharyngeal dead space washout, and generation of a low level of positive end-expiratory pressure (PEEP). These physiological effects may improve oxygenation and reduce hypoxaemic events during procedural sedation.

The present study was designed as a prospective, single-centre, age-stratified, parallel-group randomized controlled trial to compare HFNO and COT in adult (<65 years) and geriatric (≥65 years) patients undergoing ERCP under sedation.

A total of 100 ASA physical status I-III patients scheduled for ERCP were enrolled. Patients were stratified by age and randomized in a 1:1 ratio within each stratum to receive either HFNO or COT, resulting in four groups:

Adult + HFNO Geriatric + HFNO Adult + COT Geriatric + COT Sedation was standardized across groups. All patients received pre-procedural midazolam and topical lidocaine anesthesia. Sedoanalgesia was achieved using fentanyl and propofol, followed by maintenance with a ketofol infusion (ketamine-propofol mixture). Drug dosages were adjusted according to age and clinical response. Standard intra-procedural monitoring included heart rate, non-invasive blood pressure, peripheral oxygen saturation (SpO₂), and end-tidal carbon dioxide (EtCO₂).

HFNO was delivered at a flow rate of 50 L/min with FiO₂ of 0.50 and temperature of 37°C. In cases of desaturation, flow was increased up to 60 L/min and FiO₂ up to 100% if required. Conventional oxygen therapy consisted of 4 L/min oxygen via nasal cannula.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Namigar Turgut
  • İ̇stanbul
    • Beşiktaş, İ̇stanbul, Turkey (Türkiye)
      • Prof.Dr.Cemil Taşcıoğlu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Patients scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP)
• Planned sedation with monitored anesthesia care
• ASA physical status I-III
• Ability to provide written informed consent
• Adult group: 18-64 years
• Geriatric group: ≥65 years

Exclusion Criteria:

• Severe cardiac, pulmonary, renal, neurological, or hepatic disease
• Baseline hypotension (systolic arterial pressure <90 mmHg) or uncontrolled hypertension (systolic arterial pressure >170 mmHg, diastolic pressure >100 mmHg)
• Pre-existing hypoxaemia (SpO₂ <90%)
• Known hypersensitivity to study medications or a history of sedation-related adverse events
• Use of sedative medication within 24 hours prior to the procedure
• Refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFNO; Patients receiving high-flow nasal oxygen during ERCP. Intervention: Type: Device Name: High-flow nasal oxygen	Device: HFNO; Heated and humidified high-flow nasal oxygen delivered during ERCP under sedation using a high-flow nasal cannula system. Oxygen was administered at a flow rate of 50 L/min with an initial FiO₂ of 0.50 and temperature set at 37°C. In cases of oxygen desaturation (SpO₂ ≤90%), flow was increased up to 60 L/min and FiO₂ up to 1.0 if required. Continuous monitoring of SpO₂, heart rate, blood pressure, and end-tidal CO₂ was performed throughout the procedure.
Active Comparator: Conventional Oxygen Therapy; Patients receiving low-flow oxygen via nasal cannula during ERCP. Intervention: Type: Device Name: Conventional oxygen therapy	Device: Conventional Oxygen Therapy; Conventional low-flow oxygen therapy delivered via standard nasal cannula during ERCP under sedation. Oxygen was administered at a fixed flow rate of 4 L/min. Patients were continuously monitored for oxygen saturation, heart rate, blood pressure, and end-tidal CO₂ throughout the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of hypoxemia during ERCP	During the ERCP procedure

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): October 15, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 21, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ERCP; geriatric; procedural sedation; high-flow nasal oxygen; Hemodynamic Instability; hypoxaemia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia
• Other Study ID Numbers: Tascıoglu-HFNO-ERCP-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No