Endoscopic Retrograde Cholangiopancreatography, Hypoxemia
Conditions
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.
Interventions
DEVICEHigh-flow nasal canula
Heated and humidified high-flow oxygen therapy delivered through a nasal cannula during ERCP under sedation
DEVICEMicrostream advance nasal cannula
Oxygen support delivered through the Microstream Advance nasal cannula during ERCP under sedation.
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the nature of the oxygen delivery devices, masking of participants and care providers was not feasible.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Desaturation During ERCP | During the ERCP procedure | Comparison of the frequency of oxygen desaturation episodes between HFNC and Microstream Advance nasal cannula groups during ERCP under sedation. |
Countries
Turkey (Türkiye)
Contacts
CONTACTVolkan Alparslan, M.D.
PRINCIPAL_INVESTIGATORVolkan Alparslan, M.D.
Kocaeli University
Outcome results
None listed