DesaturationPrePAP-ERCPNCT07056075
Prevention of Desaturations Using Positive Airway Pressure or Capnometry During ERCP
A study testing Nasal PAP Ventilation System, Low Flow Oxygen and Capnometry in people with Desaturation and Hypoxemia, run by Karl Landsteiner University of Health Sciences at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Desaturation, Hypoxemia, ERCP
- What is being tested?
- Nasal PAP Ventilation System, Low Flow Oxygen and Capnometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 2 sitesAustria
- Study dates
- 7 Jul 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing an interventional (intent) ERCP procedure
- 18-99 years
- Male or female
- Nurse-administered sedation
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites, 2 recruiting
- Recruiting
Division of Gastroenterology and Hepatology, Department of Medicine, Medical University Graz
Graz
Florian Rainer, MD, +43 316 385-14388, endoskopieukim@uniklinikum.kages.at
- Recruiting
Department of Internal Medicine 2, University Hospital of St Pölten
Sankt Pölten, 3100
Julian Prosenz, MD, +43 2742 9004 - 12311, Interne2@stpolten.lknoe.at
About this study
Official title: 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.
- Conditions
- Desaturation, Hypoxemia, ERCP
- Being tested
- Nasal PAP Ventilation System, Low Flow Oxygen, Capnometry
- Keywords
- ERCP, Sedation-related adverse events, desaturation, trial
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal PAP Ventilation SystemDevice
Also called nasal positive airway pressure
medical devices that provide nasal positive airway pressure ventilation during endoscopy
Low Flow OxygenDevice
low flow oxygen though nasal cannula
CapnometryDevice
capnometry measurement
| Study group | Role | What they receive |
|---|---|---|
| PAP group | Experimental | Nasal PAP Ventilation System Receives: Device: Nasal PAP Ventilation System |
| Control group | Placebo comparator | Standard management consisting of low-flow oxygen through nasal cannula Receives: Device: Low Flow Oxygen |
| Capnometry group | Active comparator | capnometry and low-flow oxygen through nasal cannula Receives: Device: Low Flow Oxygen; Device: Capnometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during endoscopic retrograde cholangio-pancreatography
Secondary outcomes (11)
Difference in desaturation rate
Differences of rates of desaturations (i.e., SpO2 <85% for any duration) across the three groups
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: during endoscopic retrograde cholangio-pancreatography
Lowest SpO2
Lowest SpO2 values across the three groups
Measured: during endoscopic retrograde cholangio-pancreatography
Median procedure length
Median procedure length (min) across the three groups
Measured: 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
Measured: Periprocedural
Rate of sedation-related adverse events
Rate of sedation-related adverse events across the three groups
Measured: 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.
Measured: from ERCP up to 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start7 Jul 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DesaturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Julian Prosenz, Karl Landsteiner University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056075
- Sponsor's protocol ID
- PrePAP-ERCP
- Acronym
- PrePAP-ERCP
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07056075
- Acronym / sponsor ID
- PrePAP-ERCP / PrePAP-ERCP
- Conditions
- Desaturation, Hypoxemia, ERCP
- Keywords
- ERCP, Sedation-related adverse events, desaturation, trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Karl Landsteiner University of Health SciencesUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAP group | Experimental | Device: Nasal PAP Ventilation SystemNasal PAP Ventilation System |
| Control group | Placebo comparator | Device: Low Flow OxygenStandard management consisting of low-flow oxygen through nasal cannula |
| Capnometry group | Active comparator | Device: Low Flow Oxygen, Device: Capnometrycapnometry and low-flow oxygen through nasal cannula |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing an interventional (intent) ERCP procedure
- 18-99 years
- Male or female
- Nurse-administered sedation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal PAP Ventilation SystemAlso: nasal positive airway pressuremedical devices that provide nasal positive airway pressure ventilation during endoscopy | Device | PAP group |
| Low Flow Oxygenlow flow oxygen though nasal cannula | Device | Capnometry group, Control group |
| Capnometrycapnometry measurement | Device | Capnometry group |
Primary outcome
Difference in desaturation rate
Time frame: during endoscopic retrograde cholangio-pancreatography
Differences of rates of desaturations (i.e., SpO2 <85% for any duration) of the PAP group vs. the standard management group
11 secondary outcomes
Difference in desaturation rate
Time frame: during endoscopic retrograde cholangio-pancreatography
Difference in desaturation rate
Time frame: during endoscopic retrograde cholangio-pancreatography
Difference in desaturation rate
Time frame: during endoscopic retrograde cholangio-pancreatography
Rates of interventions for hypoxemic events
Time frame: during endoscopic retrograde cholangio-pancreatography
Rates of interventions for hypoxemic events
Time frame: during endoscopic retrograde cholangio-pancreatography
Rates of interventions for hypoxemic events
Time frame: during endoscopic retrograde cholangio-pancreatography
Lowest SpO2
Time frame: during endoscopic retrograde cholangio-pancreatography
Median procedure length
Time frame: during endoscopic retrograde cholangio-pancreatography
Satisfaction with sedation
Time frame: Periprocedural
Rate of sedation-related adverse events
Time frame: during endoscopic retrograde cholangio-pancreatography
Rate of SCOPE
Time frame: from ERCP up to 30 days after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Division of Gastroenterology and Hepatology, Department of Medicine, Medical University Graz
Graz, Austria
Department of Internal Medicine 2, University Hospital of St Pölten
Sankt Pölten, Austria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal PAP Ventilation System, Low Flow Oxygen and Capnometry in people with Desaturation and Hypoxemia, run by Karl Landsteiner University of Health Sciences at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in desaturation rate (time frame: during endoscopic retrograde cholangio-pancreatography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.