High-Flow Nasal Oxygen During Endoscopic Retrograde Cholangiopancreatography In Geriatric Patients

NCT07493811 | Completed

• 1 other identifier: Tascıoglu-HFNO-ERCP-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypoxemia; Hemodynamic Instability

Keywords

ERCP; high-flow nasal oxygen; procedural sedation; geriatric; hypoxaemia; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxemia during ERCP

  During the ERCP procedure

Study Arms (2)

HFNO

EXPERIMENTAL

Patients receiving high-flow nasal oxygen during ERCP. Intervention: Type: Device Name: High-flow nasal oxygen

Device: HFNO

Conventional Oxygen Therapy

ACTIVE COMPARATOR

Patients receiving low-flow oxygen via nasal cannula during ERCP. Intervention: Type: Device Name: Conventional oxygen therapy

Device: Conventional Oxygen Therapy

Interventions

HFNO DEVICE

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.

HFNO

Conventional Oxygen Therapy DEVICE

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.

Conventional Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Prof.Dr.Cemil Taşcıoğlu City Hospital

Beşiktaş, İ̇stanbul, Turkey (Türkiye)

Location

Namigar Turgut

Istanbul, Turkey (Türkiye)

Location

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 25, 2026
• Study Start: April 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 30, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)