Nctid:
NCT06224426
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}, {"id"=>"D000083242", "term"=>"Ischemic Stroke"}, {"id"=>"D000007511", "term"=>"Ischemia"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "asFound"=>"Ischemic", "relevance"=>"HIGH"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M20600", "name"=>"Hyperoxia", "relevance"=>"LOW"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M18307", "name"=>"Propofol", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M1696", "name"=>"Remifentanil", "relevance"=>"LOW"}, {"id"=>"M19684", "name"=>"Sufentanil", "relevance"=>"LOW"}, {"id"=>"M1666", "name"=>"Rocuronium", "relevance"=>"LOW"}, {"id"=>"M117729", "name"=>"Dsuvia", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Adjuvants, Anesthesia", "abbrev"=>"AdjAn"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-21", "studyFirstSubmitDate"=>"2023-12-17", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-23", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"symptomatic ICH", "timeFrame"=>"24±12 hours after EVT", "description"=>"defined as the presence of hemorrhage on CT at 24±12 h accompanied by an NIHSS score increase≥4"}, {"measure"=>"all-cause mortality at 90 days", "timeFrame"=>"90 days after stroke onset", "description"=>"deaths from any cause during the 3-month follow-up period"}, {"measure"=>"stroke-related death", "timeFrame"=>"within 7 days after endovascular therapy", "description"=>"typically defined as death directly attributable to the stroke and its complications, encompassing but not limited to severe cerebral edema, brain herniation, infections, cardiac diseases, pulmonary embolism, and deep vein thrombosis occurring during the acute phase of AIS"}, {"measure"=>"Postoperative baseline PaCO2", "timeFrame"=>"From the end of the intervention procedure until the time just before the tracheal tube is removed.", "description"=>"Arterial partial oxygen pressure based on arterial blood gas"}, {"measure"=>"Postoperative baseline oxygenation index", "timeFrame"=>"From the end of the intervention procedure until the time just before the tracheal tube is removed.", "description"=>"oxygenation index=PaCO2/FiO2"}], "primaryOutcomes"=>[{"measure"=>"the incidence of early neurological improvement (ENI)", "timeFrame"=>"24±2 hours after EVT", "description"=>"ENI is defined as an NIHSS score of \\<10 points at 24±2 hours after EVT"}], "secondaryOutcomes"=>[{"measure"=>"ΔNIHSS at 24±2 hours after EVT", "timeFrame"=>"24±2 hours after EVT", "description"=>"baseline NIHSS score - NIHSS score at 24±2 h"}, {"measure"=>"overall mRS distribution at 90 days", "timeFrame"=>"90 days after stroke onset", "description"=>"modified Rankin scale (mRS) scores are distributed between 0 and 6"}, {"measure"=>"favorable functional outcome", "timeFrame"=>"90 days after stroke onset", "description"=>"an mRS score of 0-2 at 90 days"}, {"measure"=>"early neurological deterioration (END)", "timeFrame"=>"1 day after reperfusion therapy", "description"=>"an increase of ≥4 from the baseline NIHSS score on day 1 after reperfusion therapy in AIS patients"}, {"measure"=>"Postoperative pulmonary complications", "timeFrame"=>"within 7 days after endovascular therapy", "description"=>"defined as a composite measure encompassing pulmonary infections, atelectasis, pleural effusion, respiratory failure, bronchospasm, and pneumothorax"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Endovascular therapy", "Acute ischemic stroke", "Normobaric hyperoxia", "Early neurological improvement", "General anesthesia"], "conditions"=>["Ischemic Stroke"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to compare the effects of different concentrations of normobaric oxygen on early neurological improvement in acute ischemic stroke (AIS) patients receiving endovascular therapy (EVT). The main questions it aims to answer are:\n\n* Evaluating the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function after EVT.\n* Evaluating the safety of high and low normobaric oxygen concentration in patients with ischemic stroke.\n\nParticipants will (1) receive EVT under general anesthesia; (2) be randomly assigned 1:1 to receive oxygen therapy with FiO2=80% or FiO2=30% through endotracheal intubation during the operation, and the gas flow rate was set at 4L /min.", "detailedDescription"=>"The optimal fraction of inspired oxygen (FiO2) during EVT under general anesthesia is currently uncertain. This is a randomized controlled trial (RCT) designed to assess the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function following EVT. It is a prospective, open-label, parallel-design RCT planned to be conducted at Beijing Tiantan Hospital, Capital Medical University. It is anticipated that 200 cases of AIS patients undergoing EVT under general anesthesia will be consecutively enrolled from 2024 to 2026. Eligible participants will be randomly assigned in a 1:1 ratio. After general anesthesia induction, patients will receive continuous inhalation of oxygen with either FiO2=80% or FiO2=30% through endotracheal intubation until the end of the procedure, with a gas flow rate set at 4 L/min. The positive end-expiratory pressure (PEEP) is uniformly set to 5 cmH2O to balance its effect on pulmonary oxygen delivery. The primary outcome will be the occurrence of early neurological improvement (NIHSS score of 10 points 24±2 hours after EVT). Safety outcomes include potential adverse events such as site infection, three-month mortality, etc."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age ≥18 years.\n* Anterior circulation occlusive stroke was confirmed by CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA), and occlusions of the terminal internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA) were involved.\n* NIHSS score at admission: 6-25.\n\nExclusion Criteria:\n\n* Stroke onset at 6-24 hours with a mismatched area \\< 15 ml was assessed by CT perfusion imaging (CTP).\n* Significant dysfunction before stroke was defined as a modified Rankin scale (mRS) score ≥2.\n* The condition was complicated by severe agitation and seizures.\n* Evidence of intracranial hemorrhage at admission.\n* Pulmonary disease complicated by impaired gas exchange.\n* An oxygen mask or ventilator must be used before anesthesia to maintain a SpO2≥94%.\n* Loss of airway protective reflex or vomiting aspiration upon admission."}, "identificationModule"=>{"nctId"=>"NCT06224426", "acronym"=>"Oxy-TARGET", "briefTitle"=>"Oxygen Concentration Target in Stroke Endovascular Treatment", "organization"=>{"class"=>"OTHER", "fullName"=>"Beijing Tiantan Hospital"}, "officialTitle"=>"Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)", "orgStudyIdInfo"=>{"id"=>"zkd20231121"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Normobaric high-concentration oxygen (NBHO) group", "description"=>"After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 µg/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBHO group will adjust the FiO2 at 80% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 µg/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed.", "interventionNames"=>["Other: Normobaric high-concentration oxygen"]}, {"type"=>"EXPERIMENTAL", "label"=>"Normobaric low-concentration oxygen (NBLO) group", "description"=>"After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 µg/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBLO group will adjust the FiO2 at 30% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 µg/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed.", "interventionNames"=>["Other: Normobaric low-concentration oxygen"]}], "interventions"=>[{"name"=>"Normobaric high-concentration oxygen", "type"=>"OTHER", "description"=>"During endovascular therapy, eligible participants will receive FiO2=80% through endotracheal intubation, with a gas flow rate set at 4 L/min.", "armGroupLabels"=>["Normobaric high-concentration oxygen (NBHO) group"]}, {"name"=>"Normobaric low-concentration oxygen", "type"=>"OTHER", "description"=>"During endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min.", "armGroupLabels"=>["Normobaric low-concentration oxygen (NBLO) group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100070", "city"=>"Beijing", "state"=>"Beijing", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Ruquan Han, Ph.D", "role"=>"CONTACT", "email"=>"ruquan.han@ccmu.edu.cn", "phone"=>"86-13701285393"}], "facility"=>"Beijing Tiantan Hospital, Capital Medical University", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}], "centralContacts"=>[{"name"=>"Ruquan Han, Ph.D", "role"=>"CONTACT", "email"=>"ruquan.han@ccmu.edu.cn", "phone"=>"+86 13701285393"}, {"name"=>"Zhengfang Hu, M.D", "role"=>"CONTACT", "email"=>"huzhengfang78@163.com", "phone"=>"+86 13041084927"}], "overallOfficials"=>[{"name"=>"Ruquan Han, Ph.D", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Beijing Tiantan Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Lead Investigator", "investigatorFullName"=>"Ruquan Han", "investigatorAffiliation"=>"Beijing Tiantan Hospital"}}}}
