[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659912":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":47,"armGroups":43,"interventions":48,"overallOfficials":53,"centralContacts":57,"locations":65,"responsibleParty":82,"collaborators":43,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":43,"enrollmentInfo":94,"targetDuration":43,"studyType":97,"phases":43,"briefSummary":98,"conditions":99,"keywords":43,"overallStatus":68,"whyStopped":43,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Any sedation-related adverse event (SRAE) requiring clinical intervention and\u002For leading to procedure termination","* Hypoxia (SpO₂ \\\u003C 90%)\n* Treatment\u002Fescalation for hypoxia (increase O₂ flow, jaw thrust, bag-valve-mask ventilation, nasal high-flow therapy, intubation)\n* Hypotension (MAP \\\u003C 65 mmHg)\n* Blood pressure support (fluid administration, vasopressors\u002Fcatecholamines)\n* Bradycardia (heart rate \\\u003C 50\u002Fmin)\n* Treatment of bradycardia (pharmacological)\n* Sedation-related termination of the procedure\n* Resuscitation and\u002For death","periprocedural",[14,17,20,23,26,30,33,37,40],{"measure":15,"description":16,"timeFrame":12},"Component and severity breakdown of the primary endpoint","• Incidence of each individual SRAE component (hypoxemia, hypotension, bradycardia, intubation, procedure termination, resuscitation\u002Fdeath)",{"measure":18,"description":19,"timeFrame":12},"Duration of the intervention and sedation","* Procedure duration (minutes)\n* Sedation duration (minutes)\n* Length of stay in endoscopy ward after procedure (minutes)",{"measure":21,"description":22,"timeFrame":12},"resource usage","* Total propofol dose (mg)\n* Total midazolam dose (mg)\n* Additional sedatives\u002Fanalgesics (mg)",{"measure":24,"description":25,"timeFrame":12},"requirement of oxygen therapy","* Oxygen flow via nasal cannula at the start of intervention\n* High-flow nasal therapy parameters at the start of intervention",{"measure":27,"description":28,"timeFrame":29},"Incidence of additional interventions\u002Fprocedures\u002Fmonitoring","* Incidence of Repeat endoscopy\n* Incidence of requirement for Surgery\n* Incidence of requirement for Interventional radiology\n* Incidence of ICU admission","up to 30 days after the endoscopic intervention",{"measure":31,"description":32,"timeFrame":29},"Patient-reported outcome","Sedation satisfaction questionnaire (prior to discharge)",{"measure":34,"description":35,"timeFrame":36},"Procedure-related (intervention-related) adverse events","* Incidence of intraprocedural bleeding requiring intervention\n* Incidence of postprocedural bleeding requiring intervention\n* Incidence of perforation\n* Incidence of post-ERCP pancreatitis\n* Incidence of post-ERCP cholangitis","periprocedural and 30 days after the endoscopic intervention",{"measure":38,"description":39,"timeFrame":12},"Effectiveness outcomes","Rate of Technical success (depending on indication)",{"measure":41,"description":42,"timeFrame":29},"30 day outcome","* 30-day mortality\n* 30-day readmission",null,{"allocation":43,"interventionModel":43,"interventionModelDescription":43,"primaryPurpose":43,"observationalModel":45,"timePerspective":46,"maskingInfo":43},"COHORT","PROSPECTIVE","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.",[49],{"type":50,"name":51,"description":52,"armGroupLabels":43,"otherNames":43},"DRUG","Sedation during interventional endoscopy","No study-specific intervention is performed and that patients receive standard-of-care sedation.",[54],{"name":55,"affiliation":5,"role":56},"Benedikt Schaefer, MD, PhD","PRINCIPAL_INVESTIGATOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":43,"email":62},"Arno Hofer, MD","CONTACT","+4351250424019","arno.hofer@tirol-kliniken.at",{"name":64,"role":60,"phone":43,"phoneExt":43,"email":43},"Andreas Schmiderer, MD",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Medical University of Innsbruck","RECRUITING","Innsbruck","Tyrol","6020","Austria","AT",{"type":75,"coordinates":76},"Point",[77,78],11.39454,47.26266,{"lat":78,"lon":77},[81],{"name":59,"role":60,"phone":61,"phoneExt":43,"email":62},{"type":83,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100659912","safety-of-sedation-during-interventional-endoscopy-100659912",false,"NCT07872657","Safety of Sedation During Interventional Endoscopy","Safety of Sedation During Interventional Endoscopy - A Non-interventional Study","SCOPE-SAFE","Inclusion Criteria:\n\n1. Patients ≥18 years of age at time of consent\n2. Ability to understand and willingness to sign and date written informed consent document\n3. Patients who undergo an interventional endoscopic procedure at Innsbruck University Hospital (ERCP, interventional EUS, interventional EGD).\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Inability to consent\n3. Respiratory instability before start of intervention (SpO2 \\\u003C90 %)\n4. Oxygen treatment via nasal cannula \\>3 l\u002Fmin before start of intervention\n5. Hemodynamic instability before start of intervention (MAP \\\u003C 65 mmHg and\u002For vasopressor\u002Fcatecholamine therapy and\u002For heart rate \\\u003C50\u002Fmin)","ALL","18 Years",{"count":95,"type":96},500,"ESTIMATED","OBSERVATIONAL","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.\n\nAt 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.",[100,101],"Sedation Complication","Sedation During GI Endoscopy","2026-10-08",{"date":104,"type":105},"2026-10-13","ACTUAL",{"date":107,"type":105},"2026-08-12",{"date":109,"type":96},"2031-10",{"name":5,"class":6},1]