NCT07056075 Prevention of Desaturations Using Positive Airway Pressure or Capnometry During ERCP
| NCT ID | NCT07056075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karl Landsteiner University of Health Sciences |
| Condition | Desaturation |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2025-07-07 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Although sedation during endoscopy is sufficiently safe, desaturations are among the most common side effects of endoscopic retrograde cholangiopancreatography (ERCP) procedures, occurring in approximately 20-30% of cases. Sedation during endoscopy increases the complication rate, and a significant proportion of severe and serious side effects are respiratory/airway-related. However, most patients require sedation to complete the procedure and achieve adequate outcomes during therapeutic ERCP. Therefore, improved measures to increase ERCP safety are needed. Since the demand for anesthesia in many centers already (far) exceeds current capacities, performing additional ERCPs under general anesthesia is not an option. Innovative ways to improve cardiorespiratory monitoring or respiratory management during ERCP could offer a solution without significantly increasing costs. Fortunately, dedicated devices for respiratory management and/or monitoring during endoscopy already exist, but their impact on improving patient safety has not yet been well studied. Therefore, the aim of this prospective, randomized, open-label, non-interventional study is to investigate the effects of non-invasive airway management and respiratory monitoring devices on desaturation rate during endoscopic retrograde cholangiopancreatography. For this purpose, 288 adult patients (male and female, 18+ years) undergoing ERCP for medical reasons will be enrolled and randomized to one of three groups: (i) airway management using positive airway pressure (PAP group), (ii) additional monitoring using capnography (capnography group), and (iii) a control group with standard monitoring/treatment (i.e., 2 L O2/min via nasal cannula) (control group). Patients are monitored during the ERCP procedure according to medical standards (non-invasive blood oxygen saturation measurement = SpO2, regular non-invasive blood pressure measurement, pulse), and all desaturation events (defined as an SpO2 \<85% for any duration according to guidelines) are recorded and treated according to guideline recommendations (the studies do not specify any measures for the (non-)treatment of desaturations). After the procedure, patients are followed (passively) for 30 days (review of medical records) to record late complications. The main outcome parameter is the comparison of the desaturation rate in the PAP versus the control group.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07056075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Desaturation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07056075 currently recruiting?
Yes, NCT07056075 is actively recruiting participants. Visit ClinicalTrials.gov or contact Karl Landsteiner University of Health Sciences to inquire about joining.
Where is the NCT07056075 trial being conducted?
This trial is being conducted at Graz, Austria, Sankt Pölten, Austria.
Who is sponsoring the NCT07056075 clinical trial?
NCT07056075 is sponsored by Karl Landsteiner University of Health Sciences. The trial plans to enroll 288 participants.