Preventing oxygen drops during ERCP with nasal PAP or capnometry
A Randomized, Controlled, Unblinded Trial Evaluating the Impact of Positive Airway Pressure and Capnometry Compared to Standard Management on the Rate of Desaturations During Nurse-administered Sedation ERCP
We'll try whether using nasal positive airway pressure or capnometry with low-flow oxygen during sedated ERCP reduces oxygen drops in adults receiving nurse-administered sedation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Karl Landsteiner University of Health Sciences Academic / other |
| Locations | 2 sites (Graz and 1 other locations) |
| Trial ID | NCT07056075 on ClinicalTrials.gov |
What this trial studies
This interventional study compares different respiratory management and monitoring approaches during interventional ERCP performed with nurse‑administered sedation. Adults (18–99) undergoing ERCP are assigned to receive nasal positive airway pressure ventilation, capnometry monitoring with low‑flow oxygen, or standard low‑flow oxygen, and are followed for desaturation events and other respiratory complications. Continuous cardiorespiratory data are collected during and immediately after the procedure to compare frequency and severity of hypoxemic episodes between groups. The study is conducted at two Austrian centers (Medical University of Graz and University Hospital of St Pölten).
Who should consider this trial
Good fit: Adults aged 18–99 who are scheduled for an interventional ERCP under nurse‑administered sedation, are not pregnant, and do not require planned intubation or anesthesiologist backup are the intended participants.
Not a fit: Patients who require general anesthesia or intubation, have a tracheostomy, are pregnant, or have a known propofol allergy are excluded and unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, these approaches could reduce the rate and severity of sedation-related oxygen drops during ERCP and improve patient safety without needing more general anesthesia resources.
How similar studies have performed: Capnography has been shown to detect hypoventilation earlier than pulse oximetry in endoscopy settings, but evidence that monitoring or adjunctive nasal PAP consistently reduces serious clinical outcomes is limited and nasal PAP use during ERCP is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * undergoing an interventional (intent) ERCP procedure * 18-99 years * Male or female * Nurse-administered sedation Exclusion Criteria: * History of allergic reaction to Propofol * Tracheostomy * Procedure requiring intubation, general anesthesia, or anesthesiologist backup (acute exacerbation of obstructive lung disease, acute congestive heart failure, supra-glottic or sub-glottic tumor, septic shock, e.g.) according to the endoscopist in charge * Pregnant patients
Where this trial is running
Graz and 1 other locations
- Division of Gastroenterology and Hepatology, Department of Medicine, Medical University Graz — Graz, Austria (Recruiting)
- Department of Internal Medicine 2, University Hospital of St Pölten — Sankt Pölten, Austria (Recruiting)
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.