Prevention of Desaturations Using Positive Airway Pressure or Capnometry During ERCP (PrePAP-ERCP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxemia; ERCP; Desaturation
• Intervention / Treatment: Device: Nasal PAP Ventilation System; Device: Low Flow Oxygen; Device: Capnometry

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Recruiting
    • Division of Gastroenterology and Hepatology, Department of Medicine, Medical University Graz
    • Contact: Florian Rainer, MD; Phone Number: +43 316 385-14388; Email: endoskopieukim@uniklinikum.kages.at
  • Sankt Pölten, Austria, 3100
    • Recruiting
    • Department of Internal Medicine 2, University Hospital of St Pölten
    • Contact: Julian Prosenz, MD; Phone Number: +43 2742 9004 - 12311; Email: Interne2@stpolten.lknoe.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAP group; Nasal PAP Ventilation System	Device: Nasal PAP Ventilation System; medical devices that provide nasal positive airway pressure ventilation during endoscopy; Other Names: nasal positive airway pressure
Placebo Comparator: Control group; Standard management consisting of low-flow oxygen through nasal cannula	Device: Low Flow Oxygen; low flow oxygen though nasal cannula
Active Comparator: Capnometry group; capnometry and low-flow oxygen through nasal cannula	Device: Low Flow Oxygen; low flow oxygen though nasal cannula; Device: Capnometry; capnometry measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in desaturation rate	Differences of rates of desaturations (i.e., SpO2 <85% for any duration) of the PAP group vs. the standard management group	during endoscopic retrograde cholangio-pancreatography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in desaturation rate	Differences of rates of desaturations (i.e., SpO2 <85% for any duration) across the three groups	during endoscopic retrograde cholangio-pancreatography
Difference in desaturation rate	Differences of rates of desaturations (i.e., SpO2 <85% for any duration) of the capnometry group vs. the standard management group	during endoscopic retrograde cholangio-pancreatography
Difference in desaturation rate	Differences of rates of desaturations (i.e., SpO2 <85% for any duration) of the PAP group vs. the capnometry group	during endoscopic retrograde cholangio-pancreatography
Rates of interventions for hypoxemic events	Rates of interventions for hypoxemic events in the PAP group vs. the control group	during endoscopic retrograde cholangio-pancreatography
Rates of interventions for hypoxemic events	Rates of interventions for hypoxemic events in the PAP group vs. the capnometry group	during endoscopic retrograde cholangio-pancreatography
Rates of interventions for hypoxemic events	Rates of interventions for hypoxemic events in the capnometry group vs. the control group	during endoscopic retrograde cholangio-pancreatography
Lowest SpO2	Lowest SpO2 values across the three groups	during endoscopic retrograde cholangio-pancreatography
Median procedure length	Median procedure length (min) across the three groups	during endoscopic retrograde cholangio-pancreatography
Satisfaction with sedation	Endoscopist and patient satisfaction levels concerning the procedure on a Likert scale ("Satisfaction scale" 0-10, 0=worst, 10=best) across the three groups	Periprocedural
Rate of sedation-related adverse events	Rate of sedation-related adverse events across the three groups	during endoscopic retrograde cholangio-pancreatography
Rate of SCOPE	Rate of a combined endpoint of serious adverse events and clinical outcomes (SCOPE) across the three groups SCOPE (serious adverse events and clinical outcomes in procedural endoscopy) includes: 30-day all-cause mortality, cardiopulmonary resuscitation1, unplanned intubation or non-invasive ventilation1, single or multiorgan dysfunction due to an endoscopy-related adverse event (AGREE IVa/IVb), rescue or secondary intervention (endoscopic, surgical, or interventional radiology) due to an endoscopy-related adverse event (AGREE IIIa/b), post-ERCP pancreatitis, or target not reached (with necessity of a secondary procedure) 1 AE occurring after start of the procedure (first dose of sedation administered) until patient leaves recovery room.	from ERCP up to 30 days after procedure

Collaborators and Investigators

• Sponsor: Karl Landsteiner University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 24, 2025
• First Submitted That Met QC Criteria: July 3, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ERCP; trial; desaturation; Sedation-related adverse events
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Respiratory Function Tests; Continuous Positive Airway Pressure; Capnography
• Other Study ID Numbers: PrePAP-ERCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No