About this trial
Sedation is routinely used during interventional endoscopic procedures to improve patient comfort and optimize procedural conditions. Non-anaesthesiologist-administered propofol sedation (NAPS) has been demonstrated to be safe and effective for many endoscopic procedures, including complex interventions such as endoscopic retrograde cholangiopancreatography (ERCP). However, evidence supporting its use during technically demanding or prolonged procedures and in patients with severe comorbidities (ASA class ≥ III) remains limited.
At our institution, interventional endoscopic procedures have been routinely performed for many years using standardized NAPS protocols, including in higher-risk patients, with comprehensive staff training, continuous patient monitoring, supplemental oxygen administration, and immediate access to an emergency response team. This non-interventional observational study will prospectively collect data on sedation practices, procedural characteristics, and sedation-related outcomes during routine interventional endoscopy without altering standard clinical care. The primary objective is to evaluate the safety of NAPS across a broad spectrum of interventional endoscopic procedures and patient risk profiles, thereby providing real-world evidence to inform future clinical practice and guideline recommendations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥18 years of age at time of consent
Ability to understand and willingness to sign and date written informed consent document
Patients who undergo an interventional endoscopic procedure at Innsbruck University Hospital (ERCP, interventional EUS, interventional EGD).
Disqualifiers
Pregnancy
Inability to consent
Respiratory instability before start of intervention (SpO2 <90 %)
Oxygen treatment via nasal cannula >3 l/min before start of intervention
Trial population
Consecutive adult patients undergoing therapeutic or advanced interventional endoscopic procedures (interventional endoscopic procedures including endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic ultrasound (EUS-guided procedures), and interventional upper gastrointestinal endoscopy (including PEG placement, endoscopic treatment of stenosis, endoscopic mucosal resection \[EMR\], endoscopic variceal band ligation \[EVBL\], radiofrequency ablation \[RFA\], foreign body removal, and other advanced endoscopic interventions). with procedural sedation as part of routine clinical care at a tertiary referral center.
Trial design
Cohort
Prospective
Treatments tested in this trial
Sedation during interventional endoscopy
DrugNo study-specific intervention is performed and that patients receive standard-of-care sedation.
Treatment groups
Trial outcomes
Primary outcomes
Any sedation-related adverse event (SRAE) requiring clinical intervention and/or leading to procedure termination
* Hypoxia (SpO₂ \< 90%) * Treatment/escalation for hypoxia (increase O₂ flow, jaw thrust, bag-valve-mask ventilation, nasal high-flow therapy, intubation) * Hypotension (MAP \< 65 mmHg) * Blood pressure support (fluid administration, vasopressors/catecholamines) * Bradycardia (heart rate \< 50/min) * Treatment of bradycardia (pharmacological) * Sedation-related termination of the procedure * Resuscitation and/or death
Secondary outcomes
Component and severity breakdown of the primary endpoint
• Incidence of each individual SRAE component (hypoxemia, hypotension, bradycardia, intubation, procedure termination, resuscitation/death)
Duration of the intervention and sedation
* Procedure duration (minutes) * Sedation duration (minutes) * Length of stay in endoscopy ward after procedure (minutes)
resource usage
* Total propofol dose (mg) * Total midazolam dose (mg) * Additional sedatives/analgesics (mg)
requirement of oxygen therapy
* Oxygen flow via nasal cannula at the start of intervention * High-flow nasal therapy parameters at the start of intervention
Sponsors and contacts
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