[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584284":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":24,"locations":29,"responsibleParty":42,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":58,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":10,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Pusan National University Yangsan Hospital","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes",null,[12],"Procedure: Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"PROCEDURE","Deep Sedation Under Proceduralist Direction with Pre-emptive Endotracheal Intubation","If an eligible subject consents to participate in the study, deep sedation and preemptive endotracheal intubation will be performed, followed by bronchoscopy. Deep sedation will be administered according to the study protocol, with final approval of sedative administration given by the proceduralist. Oxygen will be supplied at a flow rate of 4-6 L\u002Fmin via a nasal cannula before sedative administration.\n\nTo achieve a deep sedation state (Modified Observer's Assessment of Alertness\u002FSedation \\[MOAA\u002FS\\] score ≤ 2, defined as the patient not opening their eyes despite repeated verbal stimuli), an initial dose of 50 mcg fentanyl will be administered, followed by 2.5-5 mg of remimazolam. The sedation depth will be assessed every two minutes using the MOAA\u002FS score. If the patient has not reached deep sedation, an additional 2.5 mg of remimazolam will be administered.\n\nOnce deep sedation is achieved, lidocaine will be sprayed onto the trachea and bronchi using a bronchoscope for local anesthe",[9],[20],{"name":21,"affiliation":22,"role":23},"Hee Yun Seol, MD, PhD","Pusan National University Yangsan Hospital, Yangsan, South Korea","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","82-55-360-3854","seolhy@hotmail.com",[30],{"facility":5,"status":31,"city":32,"state":10,"zip":10,"country":33,"countryCode":10,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Yangsan","South Korea",{"type":35,"coordinates":36},"Point",[37,38],129.03358,35.34199,{"lat":38,"lon":37},[41],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":28},{"type":23,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Hee Yun Seol","Assistant professor for fund","100584284","deep-sedation-with-pre-emptive-endotracheal-intubation-for-advanced-bronchoscopy-procedures-100584284",false,"NCT06887335","Deep Sedation With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures","An Observational Prospective Study on the Safety and Feasibility of Deep Sedation Under Proceduralist Direction With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures","Inclusion Criteria:\n\n* Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes\n* Individuals who voluntarily consent to participate in the clinical study and sign a written informed consent form\n\nExclusion Criteria:\n\n* Patients who have experienced acute myocardial infarction or acute stroke within the past six weeks\n* Patients with contraindications to bronchoscopy (e.g., severe respiratory or cardiovascular comorbidities)\n* Patients with a history of allergy to benzodiazepines, propofol, fentanyl, or flumazenil\n* Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n* Patients with a severe hypersensitivity reaction to dextran 40\n* Patients with a history of acute angle-closure glaucoma\n* Pregnant women\n* Prisoners\n* Patients with psychiatric disorders\n* Patients classified as ASA Physical Status IV or V by the American Society of Anesthesiologists (ASA)\n* Any other patients deemed unsuitable for the clinical study by the investigator","ALL","19 Years","90 Years",{"count":56,"type":57},203,"ESTIMATED","1 Week","OBSERVATIONAL","Bronchoscopy is crucial for diagnosing and treating respiratory diseases and is recommended under sedation. Deep sedation improves patient comfort and procedural efficiency, especially in complex cases, by reducing movement and coughing. However, it carries risks of respiratory depression and airway obstruction, potentially requiring premature termination or urgent intubation. Determining the optimal timing for intubation can be challenging despite proper monitoring. To enhance safety, the investigator has performed bronchoscopy under deep sedation with preemptive intubation for years, sharing this experience with other hospitals. This study aims to evaluate its safety and feasibility through a multicenter prospective observational approach.",[62],"Lung Diseases","2025-05-27",{"date":65,"type":66},"2025-05-31","ACTUAL",{"date":68,"type":66},"2025-04-08",{"date":70,"type":57},"2026-12-31",{"name":5,"class":6},1]