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Recruiting NCT07611903

HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP

No phase Interventional Endoscopic Retrograde Cholangiopancreatography Hypoxemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-flow nasal canula, Microstream advance nasal cannula.
Who it may be relevant to
Registry conditions: Endoscopic Retrograde Cholangiopancreatography, Hypoxemia. Basic parameters: 18 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device High-flow nasal canula
    Heated and humidified high-flow oxygen therapy delivered through a nasal cannula during ERCP under sedation
  • Device Microstream advance nasal cannula
    Oxygen support delivered through the Microstream Advance nasal cannula during ERCP under sedation.

Primary outcome measures

  • Incidence of Desaturation During ERCP [Time frame: During the ERCP procedure]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Kocaeli University Faculty of Medicine Hospital — Kocaeli

Identifiers

NCT: NCT07611903 · KAEK 2024116.b1.03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗