Nctid:
NCT06232876
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M12", "name"=>"Congenital Abnormalities", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Patients will not be told whether their monitoring system. Outcomes will be evaluated from the electronic recorded by blinded investigators."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Parallel group randomized trial."}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>0}}, "statusModule"=>{"whyStopped"=>"Study not activated at site", "overallStatus"=>"WITHDRAWN", "startDateStruct"=>{"date"=>"2024-07-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2027-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-18", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-22", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-03-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Vital sign abnormalities", "timeFrame"=>"48 postoperative hours.", "description"=>"Area of vital sign abnormalities exceeded defined thresholds."}], "secondaryOutcomes"=>[{"measure"=>"Interventions", "timeFrame"=>"48 postoperative hours.", "description"=>"Unblinded continuous ward monitoring changes a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, bradycardia, and hypotension within 48 hours after major non-cardiac surgery."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Surgery"]}, "descriptionModule"=>{"briefSummary"=>"The investigators will randomize adults having major non-cardiac inpatient surgery to blinded versus unblinded continuous vital sign monitoring (saturation, ventilation, and heart rate) and hourly intermittent blood pressure recordings. The investigators will use a wearable, untethered, and battery-powered monitor (Masimo Radius VSM, Masimo, Irvine, CA) that continuously records saturation, ventilation, and heart rate, and intermittently records blood pressure.\n\nOur primary outcome will be areas-exceeding-thresholds for desaturation (\\<85%),3 bradypnea (\\<5 breaths/min), tachypnea (\\>25 breaths/min), tachycardia (heart rate \\>130 beats/min), bradycardia (heart rate \\<35 beats/min),4 mean arterial pressure (MAP) \\<65 mmHg, and MAP \\>145 mmHg. These exposure thresholds represent a balance between events that are clinically meaningful and excessive alarms that will discourage clinician participation. In unblinded patients, clinician alerts will be activated at these thresholds.", "detailedDescription"=>"Postoperative cardiovascular mortality remains common,1 and a third occurs during the initial hospitalization. Deterioration occurs over many hours but is usually unrecognized because vital signs are evaluated a 4-6-hour intervals,2 just as they were a half-century ago when patient acuity was much lower. Recognition of even subtle changes in basic vital signs may allow clinicians to detect cardiopulmonary deterioration well before serious adverse events occur. Consequent clinical interventions may in turn prevent complications, or at least moderate their severity. The investigators therefore propose a single-center randomized trial of continuous ward monitoring.\n\nThe investigators will randomize adults having major non-cardiac inpatient surgery to blinded versus unblinded continuous vital sign monitoring (saturation, ventilation, and heart rate) and hourly intermittent blood pressure recordings. The investigators will use a wearable, untethered, and battery-powered monitor (Masimo Radius VSM, Masimo, Irvine, CA) that continuously records saturation, ventilation, and heart rate, and intermittently records blood pressure.\n\nOur primary outcome will be areas-exceeding-thresholds for desaturation (\\<85%),3 bradypnea (\\<5 breaths/min), tachypnea (\\>25 breaths/min), tachycardia (heart rate \\>130 beats/min), bradycardia (heart rate \\<35 beats/min),4 mean arterial pressure (MAP) \\<65 mmHg, and MAP \\>145 mmHg. These exposure thresholds represent a balance between events that are clinically meaningful and excessive alarms that will discourage clinician participation. In unblinded patients, clinician alerts will be activated at these thresholds.\n\nSecondarily, the investigators will evaluate a composite of clinical interventions for desaturation, bradypnea, tachypnea, tachycardia, bradycardia, and hypotension. On an exploratory basis, as a pilot for a future major multi-center outcome trial, the investigators will evaluate a composite of major complications within 30 days after non-cardiac inpatient surgery including unplanned intubation, myocardial injury after non-cardiac surgery (MINS), non-fatal cardiac arrest, stroke, sepsis, in-hospital mortality, and hospital readmission.\n\nOur innovative long-term goal is to reduce in-hospital postoperative cardiovascular and pulmonary mortality. Specifically, the investigators expect to show that continuous rather than intermittent postoperative vital sign monitoring identifies unstable patients which will allow clinicians to intervene and prevent serious complications and death - thus promoting longer and healthier lives."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Are admitted to one of the wards equipped with the Masimo Radius VSM solution;\n2. Are ≥18 years old;\n3. Are designated American Society of Anesthesiologists physical status 1-4;\n4. Had major noncardiac surgery lasting at least 1.5 hours;\n5. Are expected to remain hospitalized at least two postoperative nights;\n6. Had general anesthesia with or without neuraxial anesthesia.\n\nExclusion Criteria:\n\n1. Have language, vision, or hearing impairments that may compromise continuous monitoring;\n2. Are designated Do Not Resuscitate, hospice, or receiving end of life care;\n3. Have previously participated in the study."}, "identificationModule"=>{"nctId"=>"NCT06232876", "acronym"=>"CONSTANT", "briefTitle"=>"Continuous Versus Intermittent Ward Monitoring", "organization"=>{"class"=>"OTHER", "fullName"=>"The Cleveland Clinic"}, "officialTitle"=>"Continuous Versus Intermittent Ward Monitoring on Vital Sign Abnormalities, Clinical Interventions, and Serious Complications: the CONSTANT Trial", "orgStudyIdInfo"=>{"id"=>"23-1037"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"SHAM_COMPARATOR", "label"=>"Blinded continuous monitoring", "description"=>"Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.", "interventionNames"=>["Device: Blinded continuous vital sign monitoring"]}, {"type"=>"EXPERIMENTAL", "label"=>"Unblinded continuous monitoring", "description"=>"Continuous ward monitoring with vital signs available to patients, clinicians, and investigators.", "interventionNames"=>["Device: Unblinded continuous vital sign monitoring"]}], "interventions"=>[{"name"=>"Blinded continuous vital sign monitoring", "type"=>"DEVICE", "description"=>"Continuous blinded vital sign monitoring.", "armGroupLabels"=>["Blinded continuous monitoring"]}, {"name"=>"Unblinded continuous vital sign monitoring", "type"=>"DEVICE", "description"=>"Continuous unblinded vital sign monitoring.", "armGroupLabels"=>["Unblinded continuous monitoring"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"44195", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Cleveland Clinic Foundation", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}], "overallOfficials"=>[{"name"=>"Daniel Sessler, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"The Cleveland Clinic"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Data will be shared on a collaborative basis with approval of the Steering Committee and data-use agreement."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Cleveland Clinic", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
