Endoscopic Retrograde CholangiopancreatographyNCT07611903
HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP
A study testing High-flow nasal canula and Microstream advance nasal cannula in people with Endoscopic Retrograde Cholangiopancreatography and Hypoxemia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) procedures are commonly performed under deep sedation and are associated with a risk of hypoxemia, particularly in prone or semi-prone positions. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography, Hypoxemia
- What is being tested?
- High-flow nasal canula and Microstream advance nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 84 years
- ASA physical status I-III
- Patients scheduled to undergo ERCP
- Patients who provide written informed consent
Who cannot join
- Recent history of upper respiratory tract infection
- History of lung cancer
- Chronic obstructive pulmonary disease
- Asthma
- Body mass index greater than 35 kg/m²
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University Faculty of Medicine Hospital
Kocaeli, Umuttepe, 41100
Volkan Alparslan, M.D., 05059374578, volknn@hotmail.com
About this study
Endoscopic retrograde cholangiopancreatography (ERCP) procedures are commonly performed under deep sedation and are associated with a risk of hypoxemia, particularly in prone or semi-prone positions. High-flow nasal cannula (HFNC) therapy may improve oxygenation by delivering heated and humidified oxygen at high flow rates, while the Microstream Advance nasal cannula provides simultaneous nasal oxygen delivery and oral oxygen insufflation.
This prospective randomized study aims to compare the effectiveness of HFNC and Microstream Advance nasal cannula in maintaining oxygenation during ERCP procedures. Patients undergoing ERCP will be randomized into two groups receiving either HFNC or Microstream Advance nasal cannula oxygen support during sedation.
The primary outcomes are the incidence of desaturation and oxygen reserve index (ORi) measurements during the procedure. Secondary outcomes include time to achieve target ORi levels, respiratory complications, and procedure-related adverse events.
- Being tested
- High-flow nasal canula, Microstream advance nasal cannula
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal canulaDevice
Heated and humidified high-flow oxygen therapy delivered through a nasal cannula during ERCP under sedation
Microstream advance nasal cannulaDevice
Oxygen support delivered through the Microstream Advance nasal cannula during ERCP under sedation.
| Study group | Role | What they receive |
|---|---|---|
| HFNC Group | Experimental | Participants receive oxygen support with high-flow nasal cannula (HFNC) during ERCP under sedation. Receives: Device: High-flow nasal canula |
| Microstream Advance Nasal Cannula Group | Active comparator | Participants receive oxygen support with Microstream Advance nasal cannula during ERCP under sedation. Receives: Device: Microstream advance nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Desaturation During ERCP
Comparison of the frequency of oxygen desaturation episodes between HFNC and Microstream Advance nasal cannula groups during ERCP under sedation.
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 posted28 May 2026
- Study start14 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergoing ERCP are randomized into two parallel groups receiving either high-flow nasal cannula (HFNC) oxygen therapy or Microstream Advance nasal cannula oxygen support during sedation.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Alparslan, Kocaeli University
- Investigators
- Volkan Alparslan, M.D., Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611903
- Sponsor's protocol ID
- KAEK 2024116.b1.03
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 15 Jul 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP
- ClinicalTrials.gov ID
- NCT07611903
- Acronym / sponsor ID
- KAEK 2024116.b1.03
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 May 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.
Endoscopic retrograde cholangiopancreatography (ERCP) procedures are commonly performed under deep sedation and are associated with a risk of hypoxemia, particularly in prone or semi-prone positions. High-flow nasal cannula (HFNC) therapy may improve oxygenation by delivering heated and humidified oxygen at high flow rates, while the Microstream Advance nasal cannula provides simultaneous nasal oxygen delivery and oral oxygen insufflation.
This prospective randomized study aims to compare the effectiveness of HFNC and Microstream Advance nasal cannula in maintaining oxygenation during ERCP procedures. Patients undergoing ERCP will be randomized into two groups receiving either HFNC or Microstream Advance nasal cannula oxygen support during sedation.
The primary outcomes are the incidence of desaturation and oxygen reserve index (ORi) measurements during the procedure. Secondary outcomes include time to achieve target ORi levels, respiratory complications, and procedure-related adverse events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants undergoing ERCP are randomized into two parallel groups receiving either high-flow nasal cannula (HFNC) oxygen therapy or Microstream Advance nasal cannula oxygen support during sedation.
| Arm | Type | Receives |
|---|---|---|
| HFNC Group | Experimental | Device: High-flow nasal canulaParticipants receive oxygen support with high-flow nasal cannula (HFNC) during ERCP under sedation. |
| Microstream Advance Nasal Cannula Group | Active comparator | Device: Microstream advance nasal cannulaParticipants receive oxygen support with Microstream Advance nasal cannula during ERCP under sedation. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 84 years
- ASA physical status I-III
- Patients scheduled to undergo ERCP
- Patients who provide written informed consent
Key exclusion criteria (6 listed)
- Recent history of upper respiratory tract infection
- History of lung cancer
- Chronic obstructive pulmonary disease
- Asthma
- Body mass index greater than 35 kg/m²
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 |
|---|---|---|
| High-flow nasal canulaHeated and humidified high-flow oxygen therapy delivered through a nasal cannula during ERCP under sedation | Device | HFNC Group |
| Microstream advance nasal cannulaOxygen support delivered through the Microstream Advance nasal cannula during ERCP under sedation. | Device | Microstream Advance Nasal Cannula Group |
Primary outcome
Incidence of Desaturation During ERCP
Time frame: During the ERCP procedure
Comparison of the frequency of oxygen desaturation episodes between HFNC and Microstream Advance nasal cannula groups during ERCP under sedation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
Volkan Alparslan, M.D. principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal canula and Microstream advance nasal cannula in people with Endoscopic Retrograde Cholangiopancreatography and Hypoxemia, run by Kocaeli University at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Volkan Alparslan, M.D. (05059374578, volknn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Desaturation 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 15 Jul 2026.