Prevention of Desaturations Using Positive Airway Pressure or Capnometry During ERCP

NCT07056075 | Recruiting

• 1 other identifier: PrePAP-ERCP
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

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.

Conditions

Desaturation; Hypoxemia; ERCP

Keywords

ERCP; Sedation-related adverse events; desaturation; trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Difference in desaturation rate

  during endoscopic retrograde cholangio-pancreatography

• Difference in desaturation rate

  during endoscopic retrograde cholangio-pancreatography

• Difference in desaturation rate

  during endoscopic retrograde cholangio-pancreatography

• Rates of interventions for hypoxemic events

  during endoscopic retrograde cholangio-pancreatography

• Rates of interventions for hypoxemic events

  during endoscopic retrograde cholangio-pancreatography

Study Arms (3)

PAP group

EXPERIMENTAL

Nasal PAP Ventilation System

Device: Nasal PAP Ventilation System

Control group

PLACEBO COMPARATOR

Standard management consisting of low-flow oxygen through nasal cannula

Device: Low Flow Oxygen

Capnometry group

ACTIVE COMPARATOR

capnometry and low-flow oxygen through nasal cannula

Device: Low Flow Oxygen; Device: Capnometry

Interventions

Capnometry DEVICE

capnometry measurement

Capnometry group

Nasal PAP Ventilation System DEVICE

medical devices that provide nasal positive airway pressure ventilation during endoscopy

Also known as: nasal positive airway pressure

PAP group

Low Flow Oxygen DEVICE

low flow oxygen though nasal cannula

Capnometry group; Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing an interventional (intent) ERCP procedure
• years
• Male or female
• Nurse-administered sedation

You may not qualify if:

• 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

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead

Study Sites (2)

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, 3100, Austria

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

Continuous Positive Airway Pressure; Capnography

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Researcher

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 9, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)