Desaturation, Hypoxemia, ERCP
Conditions
Keywords
ERCP, Sedation-related adverse events, desaturation, trial
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.
Interventions
DEVICENasal PAP Ventilation System
medical devices that provide nasal positive airway pressure ventilation during endoscopy
DEVICELow Flow Oxygen
low flow oxygen though nasal cannula
DEVICECapnometry
capnometry measurement
Sponsors
Karl Landsteiner University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in desaturation rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in desaturation rate | during endoscopic retrograde cholangio-pancreatography | Differences of rates of desaturations (i.e., SpO2 \<85% for any duration) across the three groups |
| Rates of interventions for hypoxemic events | during endoscopic retrograde cholangio-pancreatography | Rates of interventions for hypoxemic events in the PAP group vs. the control group |
| Lowest SpO2 | during endoscopic retrograde cholangio-pancreatography | Lowest SpO2 values across the three groups |
| Median procedure length | during endoscopic retrograde cholangio-pancreatography | Median procedure length (min) across the three groups |
| Satisfaction with sedation | Periprocedural | Endoscopist and patient satisfaction levels concerning the procedure on a Likert scale ("Satisfaction scale" 0-10, 0=worst, 10=best) across the three groups |
| Rate of sedation-related adverse events | during endoscopic retrograde cholangio-pancreatography | Rate of sedation-related adverse events across the three groups |
| Rate of SCOPE | from ERCP up to 30 days after procedure | 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. |
Countries
Austria
Outcome results
None listed