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NCT Number: NCT07493811

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof.Dr.Cemil Taşcıoğlu City Hospital, Beşiktaş, İ̇stanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of hypoxemia during ERCP

    Time frame: During the ERCP procedure

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Acronym: HFNO ERCP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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