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Prevention of Desaturations Using Positive Airway Pressure or Capnometry During ERCP

NCT ID: NCT07056075

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Desaturation Hypoxemia ERCP

Keywords

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ERCP Sedation-related adverse events desaturation trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PAP group

Nasal PAP Ventilation System

Group Type EXPERIMENTAL

Nasal PAP Ventilation System

Intervention Type DEVICE

medical devices that provide nasal positive airway pressure ventilation during endoscopy

Control group

Standard management consisting of low-flow oxygen through nasal cannula

Group Type PLACEBO_COMPARATOR

Low Flow Oxygen

Intervention Type DEVICE

low flow oxygen though nasal cannula

Capnometry group

capnometry and low-flow oxygen through nasal cannula

Group Type ACTIVE_COMPARATOR

Low Flow Oxygen

Intervention Type DEVICE

low flow oxygen though nasal cannula

Capnometry

Intervention Type DEVICE

capnometry measurement

Interventions

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Nasal PAP Ventilation System

medical devices that provide nasal positive airway pressure ventilation during endoscopy

Intervention Type DEVICE

Low Flow Oxygen

low flow oxygen though nasal cannula

Intervention Type DEVICE

Capnometry

capnometry measurement

Intervention Type DEVICE

Other Intervention Names

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nasal positive airway pressure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karl Landsteiner University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr. Julian Prosenz

Clinician Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Gastroenterology and Hepatology, Department of Medicine, Medical University Graz

Graz, , Austria

Site Status NOT_YET_RECRUITING

Department of Internal Medicine 2, University Hospital of St Pölten

Sankt Pölten, , Austria

Site Status RECRUITING

Countries

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Austria

Facility Contacts

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Florian Rainer, MD

Role: primary

Julian Prosenz, MD

Role: primary

Other Identifiers

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PrePAP-ERCP

Identifier Type: -

Identifier Source: org_study_id