[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531715":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":50,"centralContacts":57,"locations":65,"responsibleParty":108,"collaborators":23,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":23,"eligibilityCriteria":116,"healthyVolunteers":113,"sex":117,"minAge":118,"maxAge":23,"enrollmentInfo":119,"targetDuration":23,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":132,"overallStatus":67,"whyStopped":23,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Siriraj Hospital","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Titrating sedation targeting both optimal P0.1 and appropriate arousal level","EXPERIMENTAL","• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O",[13,14,15,16,17,18],"Procedure: Titrating sedation targeting both optimal P0.1 and appropriate arousal level","Drug: Fentanyl","Drug: Midazolam","Drug: Propofol","Drug: Dexmedetomidine","Drug: Cisatracurium",{"label":20,"type":21,"description":22,"interventionNames":23},"Titrating sedation targeting appropriate arousal level alone","NO_INTERVENTION","• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) according to the standard clinical practice guidelines for managing pain and agitation for patients receiving mechanical ventilation in the ICU.",null,[25,29,34,38,42,46],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":23},"PROCEDURE","* Sedation will be adjusted initially to target light sedation (RASS 0 to -2).\n* Sedative drugs include IV fentanyl (25-75 mcg\u002Fh), midazolam (0.02- 0.1 mg\u002Fkg\u002Fh), propofol (5-50 mcg\u002Fkg\u002Fmin), dexmedetomidine (0.2-0.7 mcg\u002Fkg\u002Fh).\n* Deep sedation and neuromuscular blocking agents are allowed to facilitate mechanical ventilation adjustment in patients with refractory hypoxemia.\n* Dose of cisatracurium is 0.15-0.2 mg\u002Fkg intravenous bolus, then continuous infusion at 5 -20 mg\u002Fh.\n* Then sedation adjustment will be guided by P0.1 measurement.\n* If P0.1 value of 1.5-3.5 cmH2O is achieved, no further adjustment is required.\n* If P0.1 value \\\u003C1.5, sedation will be reduced.\n* If P0.1 value \\>3.5, sedation will be increased.\n* If P0.1 value is still \\>3.5 with deep sedation, cisatracurium will be allowed and titrated until P0.1 value \\\u003C3.5 cmH2O.\n* The study protocol will be continued for 48 hours or until the patients are considered ready for weaning.",[9],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"DRUG","Fentanyl","Continuous intravenous infusion of fentanyl 25-75 micrograms\u002Fhour",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":23},"Midazolam","Continuous intravenous infusion of midazolam 0.02 - 0.1 milligrams\u002Fkilogram\u002Fhour",[9],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":23},"Propofol","Continuous intravenous infusion of propofol 5 - 50 micrograms\u002Fkilogram\u002Fminute",[9],{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":23},"Dexmedetomidine","Continuous intravenous infusion of dexmedetomidine 0.2 - 0.7 micrograms\u002Fkilogram\u002Fhour",[9],{"type":30,"name":47,"description":48,"armGroupLabels":49,"otherNames":23},"Cisatracurium","Continuous intravenous infusion of cisatracurium 5 - 20 milligrams\u002Fhour",[9],[51,55],{"name":52,"affiliation":53,"role":54},"Tanuwong Viarasilpa, MD","Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":53,"role":54},"Natdanai Ketdao, MD",[58,62],{"name":56,"role":59,"phone":60,"phoneExt":23,"email":61},"CONTACT","+66880684998","natdke@kku.ac.th",{"name":52,"role":59,"phone":63,"phoneExt":23,"email":64},"+66813469400","tanuwong.via@mahidol.ac.th",[66],{"facility":5,"status":67,"city":68,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"RECRUITING","Bangkok","10700","Thailand","TH",{"type":73,"coordinates":74},"Point",[75,76],100.50144,13.75398,{"lat":76,"lon":75},[79,80,81,82,84,86,88,90,92,94,96,98,100,102,104,106],{"name":56,"role":59,"phone":60,"phoneExt":23,"email":61},{"name":52,"role":59,"phone":63,"phoneExt":23,"email":64},{"name":52,"role":54,"phone":23,"phoneExt":23,"email":23},{"name":56,"role":83,"phone":23,"phoneExt":23,"email":23},"SUB_INVESTIGATOR",{"name":85,"role":83,"phone":23,"phoneExt":23,"email":23},"Chairat Permpikul, MD",{"name":87,"role":83,"phone":23,"phoneExt":23,"email":23},"Ranistha Ratanarat, MD",{"name":89,"role":83,"phone":23,"phoneExt":23,"email":23},"Surat Tongyoo, MD",{"name":91,"role":83,"phone":23,"phoneExt":23,"email":23},"Akekarin Poompichet, MD",{"name":93,"role":83,"phone":23,"phoneExt":23,"email":23},"Panuwat Promsin, MD",{"name":95,"role":83,"phone":23,"phoneExt":23,"email":23},"Thummaporn Naorungroj, MD",{"name":97,"role":83,"phone":23,"phoneExt":23,"email":23},"Preecha Thomrongpairoj, MD",{"name":99,"role":83,"phone":23,"phoneExt":23,"email":23},"Adhiratha Boonyasiri, MD",{"name":101,"role":83,"phone":23,"phoneExt":23,"email":23},"Chailat Maluangnon, MD",{"name":103,"role":83,"phone":23,"phoneExt":23,"email":23},"Nattapat Wongtirawit, MD",{"name":105,"role":83,"phone":23,"phoneExt":23,"email":23},"Nualnapa Kasemvilawan, RN",{"name":107,"role":83,"phone":23,"phoneExt":23,"email":23},"Metanee Promlungka, RN",{"type":54,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Natdanai Ketdao","Principal Investigator","100531715","the-efficacy-of-p01-guided-sedation-protocol-in-critically-ill-patients-receiving-invasive-mechanical-ventilation-a-randomized-controlled-trial-100531715",false,"NCT06203405","The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital\n2. Age ≥18 years old\n3. Receiving mechanical ventilation due to acute respiratory failure within 72 hours before enrollment (including patients receiving mechanical ventilation before ICU admission)\n\nExclusion Criteria:\n\n1. Patients receiving mechanical ventilation due to indications other than acute respiratory failure, such as postoperative procedures or airway protection in comatose patients\n2. Patients receiving mechanical ventilation for \\>72 hours before enrollment\n3. Patients receiving neuromuscular blocking agents prior to randomization\n4. Patients with impaired secretion clearance or upper airway obstruction anticipating a tracheostomy\n5. Patients with severe metabolic acidosis (arterial pH \\\u003C7.2) who do not have a plan for renal replacement therapy\n6. Patients intubated for neurological conditions, including intracranial hypertension, intracranial hemorrhage, large cerebral infarction, status epilepticus, or neuromuscular diseases\n7. Post-cardiac arrest patients\n8. Patients with severe liver dysfunction, including acute fulminant liver failure or cirrhosis with the Child-Pugh score B or C\n9. Patients who have a previous allergy to any of the opioid, sedation, or neuromuscular blocking drugs\n10. Pregnancy\n11. Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments\n12. Patients who refuse to participate in the study or cannot identify legally authorized representatives (LAR) within 24 hours after enrollment","ALL","18 Years",{"count":120,"type":121},214,"ESTIMATED","INTERVENTIONAL",[124],"NA","This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and arousal level compared with conventional sedation strategy (targeting arousal level alone) in patients requiring mechanical ventilation in the medical intensive care unit.",[127,128,129,130,131],"Respiratory Failure","Critical Illness","Respiratory Distress Syndrome, Adult","Lung Injury","Mechanical Ventilation Complication",[133,134,135,136,137],"acute respiratory failure","sedation","respiratory drive monitoring","mechanical ventilation","intensive care unit","2025-05-19",{"date":140,"type":141},"2025-05-22","ACTUAL",{"date":143,"type":141},"2023-12-22",{"date":145,"type":121},"2026-06-30",{"name":5,"class":6},1]