[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657977":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":55,"studyPopulation":55,"armGroups":64,"interventions":75,"overallOfficials":55,"centralContacts":55,"locations":85,"responsibleParty":103,"collaborators":55,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":55,"enrollmentInfo":115,"targetDuration":55,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":55,"overallStatus":124,"whyStopped":55,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Lowest Mean Arterial Pressure Within 10 Minutes After Induction","The lowest mean arterial pressure (MAP), measured in mmHg, recorded during the first 10 minutes after administration of the study induction drug. Blood pressure will be monitored using an arterial catheter, and MAP values will be recorded every 1-2 minutes.","From administration of the study induction drug through 10 minutes after administration.",[14,18,22,25,28,31,35,39,43,47,51],{"measure":15,"description":16,"timeFrame":17},"Average Mean Arterial Pressure During the First Hour After Induction","The arithmetic mean of all recorded mean arterial pressure (MAP) values during the first hour after administration of the study induction drug. MAP will be measured using an arterial catheter and expressed in mmHg.","From administration of the study induction drug through 60 minutes after administration.",{"measure":19,"description":20,"timeFrame":21},"Percentage of Participants With Cardiovascular Collapse","Percentage of participants requiring initiation of a vasopressor at a norepinephrine-equivalent dose greater than 0.1 micrograms\u002Fkg\u002Fmin or an increase in an existing vasopressor dose of more than 0.1 micrograms\u002Fkg\u002Fmin in norepinephrine equivalents during the assessment period.","From administration of the study induction drug through 2 minutes after tracheal intubation.",{"measure":23,"description":24,"timeFrame":17},"Percentage of Participants With Severe Hypotension","Percentage of participants with mean arterial pressure below 65 mmHg lasting at least 5 consecutive minutes during the first hour after administration of the study induction drug. Measurements obtained during cardiac arrest will be excluded from this assessment.",{"measure":26,"description":27,"timeFrame":17},"Percentage of Participants With Severe Hypoxemia","Percentage of participants with peripheral oxygen saturation (SpO2) below 80% lasting at least 30 consecutive seconds, measured by pulse oximetry.",{"measure":29,"description":30,"timeFrame":17},"Percentage of Participants With Cardiac Arrest","Percentage of participants experiencing cardiac arrest requiring chest compressions or defibrillation during the first hour after administration of the study induction drug.",{"measure":32,"description":33,"timeFrame":34},"Time to Successful Tracheal Intubation","Time in seconds from the start of study induction drug administration to confirmation of correct tracheal tube placement by auscultation and detection of exhaled carbon dioxide. The interval will be measured using a stopwatch.","From the start of study induction drug administration until confirmation of successful tracheal intubation during the intubation procedure.",{"measure":36,"description":37,"timeFrame":38},"All-Cause Mortality Within 7 Days","Percentage of participants who die from any cause within 7 days after randomization. Vital status will be determined through medical record review or telephone follow-up.","From randomization through Day 7.",{"measure":40,"description":41,"timeFrame":42},"All-Cause Mortality Within 28 Days","Percentage of participants who die from any cause within 28 days after randomization. Vital status will be determined through medical record review or telephone follow-up.","From randomization through Day 28.",{"measure":44,"description":45,"timeFrame":46},"All-Cause Mortality During Hospitalization","Percentage of participants who die from any cause during the index hospitalization after randomization, within the maximum follow-up period of 60 days.","From randomization until hospital discharge or death, whichever occurs first, up to 60 days.",{"measure":48,"description":49,"timeFrame":50},"Cumulative Vasopressor Dose During the First 24 Hours","Total amount of all vasopressors administered during the first 24 hours after randomization, converted to norepinephrine-equivalent doses and summed for each participant. Cumulative doses will be calculated from medication administration and infusion records.","From randomization through 24 hours after randomization.",{"measure":52,"description":53,"timeFrame":54},"Duration of Invasive Mechanical Ventilation","Time in hours from tracheal intubation to the first successful liberation from invasive mechanical ventilation, determined from medical records.","From tracheal intubation until first successful liberation from invasive mechanical ventilation, with observation ending at hospital discharge or death and a maximum follow-up of 60 days.",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":55,"primaryPurpose":59,"observationalModel":55,"timePerspective":55,"maskingInfo":60},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":61,"maskingDescription":55,"whoMasked":62},"SINGLE",[63],"OUTCOMES_ASSESSOR",[65,70],{"label":66,"type":67,"description":55,"interventionNames":68},"Propofol Group","ACTIVE_COMPARATOR",[69],"Drug: Propofol",{"label":71,"type":72,"description":55,"interventionNames":73},"Esketamine Group","EXPERIMENTAL",[74],"Drug: Esketamine",[76,81],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":55},"DRUG","Esketamine","Esketamine - Intervention Description Esketamine will be administered as an intravenous bolus at a dose of 0.5-1.0 mg\u002Fkg for induction during rapid sequence intubation. The dose will be individualized according to age and hemodynamic status: 0.5 mg\u002Fkg for participants aged 65 years or older or with shock, and 1.0 mg\u002Fkg for other participants. Participants will also receive rocuronium 0.6 mg\u002Fkg intravenously for neuromuscular blockade. Intubation, monitoring, and blood pressure support will follow a standardized ICU protocol.",[71],{"type":77,"name":82,"description":83,"armGroupLabels":84,"otherNames":55},"Propofol","Propofol - Intervention Description Propofol will be administered as an intravenous bolus at a dose of 1.5 mg\u002Fkg for induction during rapid sequence intubation. Participants will also receive rocuronium 0.6 mg\u002Fkg intravenously for neuromuscular blockade. Intubation, monitoring, and blood pressure support will follow the same standardized ICU protocol used in the esketamine group.",[66],[86],{"facility":87,"status":55,"city":88,"state":55,"zip":55,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","China","CN",{"type":92,"coordinates":93},"Point",[94,95],114.26667,30.58333,{"lat":95,"lon":94},[98],{"name":99,"role":100,"phone":101,"phoneExt":55,"email":102},"Jiancheng Zhang","CONTACT","8613554105815","zhjcheng1@126.com",{"type":104,"investigatorFullName":99,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"PRINCIPAL_INVESTIGATOR","100657977","phase-4-propofol-or-esketamine-tracheal-intubation-comparison-100657977",false,"NCT07847255","Propofol or Esketamine: Tracheal Intubation Comparison","Esketamine Versus Propofol for Rapid Sequence Intubation in Critically Ill Patients: A Prospective, Randomized, Open-Label, Controlled Trial","POETIC","Inclusion Criteria:\n\n* Age 18 years or older.\n* Critically ill patient receiving care in the participating intensive care unit (ICU) and requiring emergency tracheal intubation using a rapid sequence intubation technique, as determined by the treating clinician.\n* Written informed consent provided by the participant or a legally authorized representative. Deferred consent is permitted under the protocol when the participant cannot provide consent because of critical illness, a legally authorized representative cannot be reached in time, and delaying intubation could cause irreversible harm. In these circumstances, written informed consent must be obtained as soon as possible and no later than 72 hours after intubation.\n\nExclusion Criteria:\n\n* Emergency tracheal intubation during cardiac arrest.\n* Known or suspected elevated intracranial pressure.\n* Severe bradycardia, defined as a heart rate below 50 beats per minute.\n* Known allergy to esketamine or propofol.\n* Pregnancy or breastfeeding.\n* Untreated or inadequately treated hyperthyroidism.\n* Severe chronic liver disease, classified as Child-Pugh class C.\n* Alcohol or opioid dependence.\n* Psychiatric illness or severe cognitive impairment.","ALL","18 Years",{"count":116,"type":117},130,"ESTIMATED","INTERVENTIONAL",[120],"PHASE4","The goal of this clinical trial is to compare how esketamine and propofol affect blood pressure in critically ill adults who need a breathing tube in an intensive care unit (ICU). Placing a breathing tube into the windpipe is called tracheal intubation. Medicines are given to make patients unconscious and relax their muscles so the tube can be placed quickly. This procedure is called rapid sequence intubation. Blood pressure can fall during this process.\n\nThe main question is whether esketamine leads to a higher minimum blood pressure than propofol during the first 10 minutes after the study medicine is given. Researchers will measure mean arterial pressure, which is the average pressure in the arteries during one heartbeat. The study will also compare the need for medicines to support blood pressure, complications around tube placement, survival, time on a breathing machine, and length of ICU stay.\n\nThe study will enroll 130 adults aged 18 years or older at one hospital in China. Participants will be assigned by chance, like flipping a coin, to receive either esketamine or propofol through a vein before tube placement. Each participant will have an equal chance of receiving either medicine. The treating team will know which medicine is given. Both groups will receive a muscle relaxant and follow the same standard procedures for tube placement and blood pressure support.\n\nThe care team will closely monitor blood pressure, heart rate, and blood oxygen levels before and after tube placement. Researchers will record side effects, including high blood pressure, a fast heart rate, and confusion after the procedure. Participants will continue to receive usual ICU care and will be followed until hospital discharge or death, for up to 60 days.",[123],"Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit","NOT_YET_RECRUITING","2026-09-23",{"date":127,"type":128},"2026-09-29","ACTUAL",{"date":130,"type":117},"2026-10-08",{"date":132,"type":117},"2028-09-30",{"name":5,"class":6},1]