HypoxemiaHFNO ERCPNCT07493811
High-Flow Nasal Oxygen During Endoscopic Retrograde Cholangiopancreatography In Geriatric Patients
A study testing HFNO and Conventional Oxygen Therapy in people with Hypoxemia and Hemodynamic Instability, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypoxemia, Hemodynamic Instability
- What is being tested?
- HFNO and Conventional Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Prof.Dr.Cemil Taşcıoğlu City Hospital
Beşiktaş, İ̇stanbul
Namigar Turgut
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypoxemia, Hemodynamic Instability
- Being tested
- HFNO, Conventional Oxygen Therapy
- Keywords
- ERCP, high-flow nasal oxygen, procedural sedation, geriatric, hypoxaemia, Hemodynamic Instability
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNODevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HFNO | Experimental | Patients receiving high-flow nasal oxygen during ERCP.
Intervention:
Type: Device Name: High-flow nasal oxygen Receives: Device: HFNO |
| Conventional Oxygen Therapy | Active comparator | Patients receiving low-flow oxygen via nasal cannula during ERCP.
Intervention:
Type: Device Name: Conventional oxygen therapy Receives: Device: Conventional Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia during ERCP
Measured: During the ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start15 Apr 2025
- Primary completion15 Oct 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namigar Turgut, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493811
- Sponsor's protocol ID
- Tascıoglu-HFNO-ERCP-2025
- Acronym
- HFNO ERCP
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Nasal Oxygen Versus Conventional Oxygen Therapy During Sedated ERCP In Geriatric And Adult Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07493811
- Acronym / sponsor ID
- HFNO ERCP / Tascıoglu-HFNO-ERCP-2025
- Conditions
- Hypoxemia, Hemodynamic Instability
- Keywords
- ERCP, high-flow nasal oxygen, procedural sedation, geriatric, hypoxaemia, Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNO | Experimental | Device: HFNOPatients receiving high-flow nasal oxygen during ERCP. Intervention: Type: Device Name: High-flow nasal oxygen |
| Conventional Oxygen Therapy | Active comparator | Device: Conventional Oxygen TherapyPatients receiving low-flow oxygen via nasal cannula during ERCP. Intervention: Type: Device Name: Conventional oxygen therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNOHeated 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. | Device | HFNO |
| Conventional Oxygen TherapyConventional 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. | Device | Conventional Oxygen Therapy |
Primary outcome
Incidence of hypoxemia during ERCP
Time frame: During the ERCP procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNO and Conventional Oxygen Therapy in people with Hypoxemia and Hemodynamic Instability, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia during ERCP (time frame: During the ERCP procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.