HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP

NCT07611903 | Not Yet Recruiting

• 1 other identifier: KAEK 2024116.b1.03
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Endoscopic Retrograde Cholangiopancreatography; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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.

  During the ERCP procedure

Study Arms (2)

HFNC Group

EXPERIMENTAL

Participants receive oxygen support with high-flow nasal cannula (HFNC) during ERCP under sedation.

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.

Device: Microstream advance nasal cannula

Interventions

High-flow nasal canula DEVICE

Heated and humidified high-flow oxygen therapy delivered through a nasal cannula during ERCP under sedation

HFNC Group

Microstream advance nasal cannula DEVICE

Oxygen support delivered through the Microstream Advance nasal cannula during ERCP under sedation.

Microstream Advance Nasal Cannula Group

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 84 years
• ASA physical status I-III
• Patients scheduled to undergo ERCP
• Patients who provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Volkan Alparslan, M.D.

CONTACT

05059374578; volknn@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the oxygen delivery devices, masking of participants and care providers was not feasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): June 29, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share