Nctid:
NCT06227208
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012131", "term"=>"Respiratory Insufficiency"}], "ancestors"=>[{"id"=>"D012120", "term"=>"Respiration Disorders"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "relevance"=>"LOW"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "relevance"=>"LOW"}, {"id"=>"M14968", "name"=>"Respiratory Insufficiency", "asFound"=>"Respiratory Depression", "relevance"=>"HIGH"}, {"id"=>"M14957", "name"=>"Respiration Disorders", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M5317", "name"=>"Buprenorphine", "relevance"=>"LOW"}, {"id"=>"M16901", "name"=>"Tramadol", "relevance"=>"LOW"}, {"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M11982", "name"=>"Morphine", "relevance"=>"LOW"}, {"id"=>"M11671", "name"=>"Methadone", "relevance"=>"LOW"}, {"id"=>"M8418", "name"=>"Fentanyl", "relevance"=>"LOW"}, {"id"=>"M13020", "name"=>"Oxycodone", "relevance"=>"LOW"}, {"id"=>"M1800", "name"=>"Tapentadol", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antitussive Agents", "abbrev"=>"AnTuAg"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}, {"name"=>"Adjuvants, Anesthesia", "abbrev"=>"AdjAn"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>691}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-01-16", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-17", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"SpO2 <88% in the four hours following opioid administration", "timeFrame"=>"four hours following opioid administration"}], "secondaryOutcomes"=>[{"measure"=>"Respiratory deviations four hours after opioid administration", "timeFrame"=>"four hours following opioid administration", "description"=>"SpO2 \\<92%, \\<88 %, \\<85%, \\<80% and respiratory rate ≤11 min-1, ≤8 min-1, ≤5 min-1"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Opioid-induced respiratory depression", "Postoperative opioid", "Opioid-naïve patients", "Chronic opioid patients", "Desaturation", "Bradypnea", "Continuous monitoring", "Patient safety"], "conditions"=>["Medical Complication"]}, "descriptionModule"=>{"briefSummary"=>"Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients. Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Outcome: Respiratory deviations four hours after opioid administration", "detailedDescription"=>"Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients within the first four hours following opioid administration in addition to the chronic dose, using a continuously wireless monitoring system.\n\nPatients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Continuous wireless monitoring data of peripheral tissue oxygenation (SpO2) and respiratory rate (RR) was conducted in postoperative patients. Data were stratified into opioid-naïve and chronic opioid patients, based on their preoperative opioid history. Patients who did not receive opioids postoperatively were served as the control group. Data was evaluated one hour before and four hours after opioid administration. The primary outcome was the cumulative duration of SpO2 \\<88%."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"50 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients from studies WARD Surgery Observational \\[gov: NCT03491137\\] and the control group from a WARD Surgery Randomized Controlled Trial (RCT) \\[gov: NCT04640415 - submitted\\] were assessed for inclusion eligibility.", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients from studies WARD Surgery Observational \\[gov: NCT03491137\\]\n* The control group from WARD Surgery Randomized Controlled Trial \\[gov: NCT04640415\\]\n\nExclusion Criteria:\n\n* Less than 30 minutes of continuous monitoring data within the 60-minute window prior to opioid administration\n* Less than 120 minutes (\\<50% of theoretical maximum) of monitoring data available during the four-hour observation period\n* Patients who received transdermal fentanyl as postoperative opioid\n* Patients with a baseline saturation or respiratory rate below the prespecified thresholds\n* Patients with a BMI of ≥40 or diagnosed with COPD were excluded in the analysis of SpO2 \\<92%"}, "identificationModule"=>{"nctId"=>"NCT06227208", "briefTitle"=>"Postoperative Opioid and Respiratory Depression in Opioid Naive and Chronic Opioid Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Rigshospitalet, Denmark"}, "officialTitle"=>"The Impact of Postoperative Opioids on Duration and Severity of Desaturation and Bradypnea in Opioid-naïve and Chronic Opioid Patients, Assessed by Continuous Vital Sign Monitoring.", "orgStudyIdInfo"=>{"id"=>"WARD-postoperative-opioid"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Opioid-naive patients", "description"=>"Opioid-naive patients are defined as the absence of any documented opioid use in the available preoperatively medical records, and are receiving opioids postoperatively", "interventionNames"=>["Device: Continuous vital sign monitoring"]}, {"label"=>"Chronic opioid patients", "description"=>"Chronic opioid patients were defined as current or previous use of the following medications, re-gardless of the duration of use: morphine, tramadol, tapentadol, fentanyl, oxycodone, ketobe-midone, methadone, or buprenorphine. This was verified through patients' preoperative medical records. All chronic opioid users received postoperative opioids.", "interventionNames"=>["Device: Continuous vital sign monitoring"]}, {"label"=>"Control group", "description"=>"Patients who did not receive pre- or postoperative opioids were served as the overall control group.", "interventionNames"=>["Device: Continuous vital sign monitoring"]}], "interventions"=>[{"name"=>"Continuous vital sign monitoring", "type"=>"DEVICE", "description"=>"Wireless monitoring system that provided continuous, non-invasive collection of their vital signs, including peripheral oxygen saturation (SpO2) and respiratory rate (RR), for up to 92 hours following surgery or until discharge. The respiratory rate was monitored via FDA-approved Isansys Lifetouch electrocardiogram (ECG) patch, which was placed on the left side of the chest. SpO2 levels were continuously recorded using the Nonin WristOx 3150, a wrist-mounted finger oximeter.", "armGroupLabels"=>["Chronic opioid patients", "Control group", "Opioid-naive patients"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"2100", "city"=>"Copenhagen", "country"=>"Denmark", "facility"=>"Rigshospitalet", "geoPoint"=>{"lat"=>55.67594, "lon"=>12.56553}}, {"zip"=>"2400", "city"=>"Copenhagen", "country"=>"Denmark", "facility"=>"Bispebjerg Hospital", "geoPoint"=>{"lat"=>55.67594, "lon"=>12.56553}}], "overallOfficials"=>[{"name"=>"Eske Kvanner Aasvang, Professor", "role"=>"STUDY_CHAIR", "affiliation"=>"Rigshospitalet, Denmark"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Rigshospitalet, Denmark", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Bispebjerg Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor, head of research, MD, DmSci", "investigatorFullName"=>"Eske Kvanner Aasvang", "investigatorAffiliation"=>"Rigshospitalet, Denmark"}}}}
