Comparing oxygen delivery methods during ERCP procedures
Comparison of Procedural Oxygen Mask vs. High-flow Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Parallel-GroupTrial
NA · Kocaeli City Hospital · NCT06817603
This study is testing whether a special nose tube or a mask works better to keep patients' oxygen levels steady during a procedure called ERCP.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kocaeli City Hospital (other gov) |
| Locations | 1 site (Kocaeli̇, İ̇zmi̇t) |
| Trial ID | NCT06817603 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of two oxygen delivery methods, High-Flow Nasal Cannula (HFNC) and Procedural Oxygen Mask (POM), in preventing hypoxemia during Endoscopic Retrograde Cholangiopancreatography (ERCP). It is a randomized, parallel-group, prospective study involving 150 patients, who will be monitored throughout the procedure using pulse oximetry, ECG, and blood pressure monitoring. The study aims to determine which method better maintains oxygen saturation levels during this invasive procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 scheduled for ERCP with an ASA classification of 1-3.
Not a fit: Patients with a BMI over 30, respiratory issues, or those who are oxygen-dependent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved oxygen management during ERCP, reducing the risk of hypoxemia for patients.
How similar studies have performed: While there have been studies on oxygen delivery methods, this specific comparison in the context of ERCP is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-75 years * American Society of Anesthesiologists (ASA) classification of 1-2-3 * Patients scheduled for ERCP at Kocaeli City Hospital Endoscopy Unit Exclusion Criteria: * Refused to participate in the study * Had an allergy to ketamine, propofol, or midazolam * Had a BMI \>30 kg/m² * Were pregnant or in the postpartum period * Had a STOP-BANG score ≥3 * Had a history of intubation within the past 3 months * Had a history of lower respiratory tract infection within the past 3 months * Had a history of intensive care unit (ICU) admission within the past 3 months * Had a tracheostomy or a history of tracheostomy placement * Were oxygen-dependent * Had lung cancer or a history of lung surgery * Had asthma, COPD, or interstitial lung disease
Where this trial is running
Kocaeli̇, İ̇zmi̇t
- Kocaeli City Hospital — Kocaeli̇, İ̇zmi̇t, Turkey (RECRUITING)
Study contacts
- Study coordinator: Bedirhan Günel, MD
- Email: bedirhangunel71@gmail.com
- Phone: 05069647656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoxemia, Endoscopic Retrograde Cholangiopancreatography, Airway Management