HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorKocaeli University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 84 years
ASA physical status I-III
Patients scheduled to undergo ERCP
Patients who provide written informed consent
Disqualifiers
Recent history of upper respiratory tract infection
History of lung cancer
Chronic obstructive pulmonary disease
Asthma
Trial design
Design model
Parallel
Treatments tested in this trial
High-flow nasal canula
DeviceHeated and humidified high-flow oxygen therapy delivered through a nasal cannula during ERCP under sedation
Microstream advance nasal cannula
DeviceOxygen support delivered through the Microstream Advance nasal cannula during ERCP under sedation.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: HFNC GroupExperimental treatment 1 intervention
Group B: Microstream Advance Nasal Cannula GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
During the ERCP procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov