[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588347":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":60,"studyPopulation":60,"armGroups":69,"interventions":82,"overallOfficials":94,"centralContacts":99,"locations":107,"responsibleParty":127,"collaborators":60,"id":130,"slug":60,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":60,"enrollmentInfo":139,"targetDuration":60,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":109,"whyStopped":60,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Leipzig University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":60},[9],{"measure":10,"description":11,"timeFrame":12},"Cardiovascular Collapse","Composite Outcome:\n\nHemodynamic Instability up to 60 minutes after start of the procedure, defined as:\n\n* any measured RRsyst \\\u003C 65 mmHg or RRsyst \\\u003C 90 mmHg for at least 30 minutes and\u002For\n* new need for Norepinephrine or increased dosage of Norepinephrine or need of a volume bolus \\> 15 ml\u002FkgKG, to sustain a MAP \\> 65 mmHg\u002FRR syst \\> 90 mmHg.\n\nand\u002For\n\nCardiopulmonary Resuscitation up to 60 minutes after start of the procedure.","From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.",[14,17,20,24,27,30,33,36,39,42,46,49,53,57],{"measure":15,"description":16,"timeFrame":12},"Hemodynamic Instability","Hemodynamic Instability up to 60 minutes after start of the procedure, defined as: - any measured RRsyst \\\u003C 65 mmHg or RRsyst \\\u003C 90 mmHg for at least 30 minutes and\u002For - new need for Norepinephrine or increased dosage of Norepinephrine or need of a volume bolus \\> 15 ml\u002FkgKG, to sustain a MAP \\> 65 mmHg\u002FRR syst \\> 90 mmHg.",{"measure":18,"description":19,"timeFrame":12},"Cardiopulmonary Resuscitation","Cardiopulmonary Resuscitation, defined as any start of chest compressions.",{"measure":21,"description":22,"timeFrame":23},"spO2 after completion of preoxygenation","spO2 \\[%\\] after completion of preoxygenation","In both groups: spO2 at the time of application of rocuronium, which will be administered after preoxygenation has been completed and mark the beginning of the intubation procedure.",{"measure":25,"description":25,"timeFrame":26},"Lowest spO2 during procedure","From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.",{"measure":28,"description":29,"timeFrame":26},"Severe desaturation spO2 \u003C 80%","Any spO2 measured below 80% during the intubation procedure.",{"measure":31,"description":32,"timeFrame":26},"Dose of Ketamine","Cumulative dose of Ketamine used.",{"measure":34,"description":35,"timeFrame":26},"Dose of Midazolam","Cumlative dose of Midazolam.",{"measure":37,"description":38,"timeFrame":26},"Endotracheal aspiration during intubation procedure","Endotracheal aspiration during intubation, defined as clinical observation by the intubating physician.",{"measure":40,"description":41,"timeFrame":26},"Number of intubation attempts","Cumulative number of intubation attempts. One attempt is defines as every new introduction of the laryngoskope through the open mouth.",{"measure":43,"description":44,"timeFrame":45},"New diagnosis of pneumonia","New diagnosis of pneumonia, defined as clinical interpretation of:\n\n* new infiltration in thoracic imaging (CT, chest xray, thoracic ultrasound)\n* proof of pathogen in respiratory material\n* worsening of oxygenation.","From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.",{"measure":47,"description":48,"timeFrame":45},"New diagnosis of pneumothorax","New diagnosis of pneumothorax, defined as:\n\n\\- proof of pneumothorax in thoracic imaging (CT, chest xray, thoracic ultrasound)",{"measure":50,"description":51,"timeFrame":52},"ICU-Mortality","ICU-Mortality, defined as death during ICU-stay","From start of the procedure (= start of preoxygenation) until discharge from ICU, assessed up to 90 days.",{"measure":54,"description":55,"timeFrame":56},"Number of ICU-free days","Number of days, in which the patient was alive outside any ICU.","From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.",{"measure":58,"description":59,"timeFrame":56},"Number of ventilator-free days","Number of days, in which the patient was alive and free of invasive mechanical ventilation.",null,{"allocation":62,"interventionModel":63,"interventionModelDescription":60,"primaryPurpose":64,"observationalModel":60,"timePerspective":60,"maskingInfo":65},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":66,"maskingDescription":60,"whoMasked":67},"SINGLE",[68],"OUTCOMES_ASSESSOR",[70,76],{"label":71,"type":72,"description":73,"interventionNames":74},"RSI","ACTIVE_COMPARATOR","Modified Rapid Sequence Induction",[75],"Procedure: Modified Rapid Sequence Induction",{"label":77,"type":78,"description":79,"interventionNames":80},"DSI","EXPERIMENTAL","Delayed Sequence Induction",[81],"Procedure: Delayed Sequence Induction",[83,89],{"type":84,"name":79,"description":85,"armGroupLabels":86,"otherNames":87},"PROCEDURE","Delayed Sequence Induction - fractional dosing of Ketamin and Midazolam until a dissociative status is achieved. Dosing should follow the clinical effect. - start of preoxygenation with Bag-Valve-Mask Device or NIV when dissociative status is achieved for at least 3 minutes. - after completion of preoxygenation: neuromuscular blockade with Rocuronium - after application of Rocuronium: Intubation via standard of care. - should apnoea occur during preoxygenation, the continuation of ventilation via Bag-Valve-Mask or NIV is recommended, but not mandatory.",[77],[88,77],"Delayed Sequence Intubation",{"type":84,"name":73,"description":90,"armGroupLabels":91,"otherNames":92},"Modified Rapid Sequence Induction - Preoxygenation FiO2 100% with Bag-Valve-Mask-Device or NIV for at least 3 Minutes. - After completion of Preoxygeniation: application of Midazolam, Ketamin and Rocuronium. - The dosing of medication is determined in advance by the operating physician. - Ventilation via Bag-Valve-Mask-device or NIV after application of rocuronium is allowed. - After application of medication: Intubation via standard of care.",[71],[93],"Rapid Sequence Intubation",[95],{"name":96,"affiliation":97,"role":98},"Anton J Pelka","Interdisciplinary Medical ICU, Leipzig Medical University Center","PRINCIPAL_INVESTIGATOR",[100,104],{"name":96,"role":101,"phone":102,"phoneExt":60,"email":103},"CONTACT","+49 341 97 12700","anton.pelka@medizin.uni-leipzig.de",{"name":105,"role":101,"phone":102,"phoneExt":60,"email":106},"Sirak Petros, Prof. Dr.","sirak.petros@uniklinik-leipzig.de",[108],{"facility":97,"status":109,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"RECRUITING","Leipzig","Saxony","04317","Germany","DE",{"type":116,"coordinates":117},"Point",[118,119],12.37129,51.33962,{"lat":119,"lon":118},[122,123,124],{"name":96,"role":101,"phone":102,"phoneExt":60,"email":103},{"name":96,"role":98,"phone":60,"phoneExt":60,"email":60},{"name":125,"role":126,"phone":60,"phoneExt":60,"email":60},"Sirak Petros, Prof. Dr. habil.","SUB_INVESTIGATOR",{"type":98,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Anton Pelka","Principal Investigator","100588347",false,"NCT06940219","Delayed Against Rapid Sequence Induction in Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation.","Delayed Against Rapid Sequence Induction in Critically Ill Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation: The DARSITUBE-study, a Monocentric Randomized Controlled Trial","DARSITUBE","Inclusion Criteria:\n\n* Adult patients 18 years or older in need of emergency endotracheal intubation in the following 60 minutes.\n* The planned operateur routinely performs endotracheal intubation in critically ill patients.\n\nExclusion Criteria:\n\n* Endotracheal Intubation performed during cardiopulmonary resuscitation or during \"unstable ROSC\", defined as Norepinephrine or Epinephrine dose \\> 0,5 µg\u002FkgKG\u002Fmin after return of spontaneous circulation.\n* Participation in the study is not warranted because of increased risk for the patient or otherwise not justifiable (e.g. active oral bleeding).\n* Known allergy against Ketamine, Esketamine, Midazolam or Rocuronium.\n* Known contraindication against Ketamine, Esketamine Midazolam or Rocuronium.\n* Known or anticipated difficult airway with indication for awake fiberoptic intubation.\n* Women with known pregnancy or breastfeeding.","ALL","18 Years",{"count":140,"type":141},200,"ESTIMATED","INTERVENTIONAL",[144],"NA","The goal of this clinical trial is to learn if it is feaseble to conduct a superiority trial comparing two methods for endotracheal intubation in critically ill patients. It will also learn about validity of outcomes regarding endotracheal intubation. The main questions it aims to answer are:\n\n* Does performing intubation via Delayed Sequence Induction lower the incidence of severe hemodynamic complications compared to Rapid Sequence Induction?\n* How are hemodynamic complications in the severely ill to be measured in order to minimize bias?\n\nParticipants will:\n\n* receive emergency endotracheal intubation via Delayed or Rapid Sequence induction\n* receive a phone call 90 days after endotracheal intubation\n* outcome parameters outside of follow up phone calls will be routinely collected during the regular ICU-stay, there won't be any additional testing",[147],"Intubation in Intensive Care Units",[149,150,151,152,153,79,154],"Intubation","Airway Management","Acute respiratory failure","Intensive Care Unit","Rapid Sequence Induction","Intubation in intensive care units","2025-07-01",{"date":157,"type":158},"2025-07-04","ACTUAL",{"date":160,"type":158},"2025-06-27",{"date":162,"type":141},"2027-11",{"name":5,"class":6},1]