Nctid:
NCT06227234
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000402", "term"=>"Airway Obstruction"}, {"id"=>"D000005547", "term"=>"Foreign Bodies"}], "ancestors"=>[{"id"=>"D000012131", "term"=>"Respiratory Insufficiency"}, {"id"=>"D000012120", "term"=>"Respiration Disorders"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M3750", "name"=>"Airway Obstruction", "asFound"=>"Airway Obstruction", "relevance"=>"HIGH"}, {"id"=>"M8671", "name"=>"Foreign Bodies", "asFound"=>"Foreign Body", "relevance"=>"HIGH"}, {"id"=>"M6867", "name"=>"Decompression Sickness", "relevance"=>"LOW"}, {"id"=>"M14968", "name"=>"Respiratory Insufficiency", "relevance"=>"LOW"}, {"id"=>"M14957", "name"=>"Respiration Disorders", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE", "maskingDescription"=>"Nil, however, Outcomes Assessor will be blinded to study hypothesis."}, "primaryPurpose"=>"OTHER", "interventionModel"=>"CROSSOVER", "interventionModelDescription"=>"Investigators will conduct an open-label, crossover, mannequin, randomized controlled trial to compare two airway clearance devices (LifeVac© and Dechoker©) with traditional abdominal thrusts as choking interventions. Participants will complete all through interventions in one of 6 randomized orders."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>132}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-08-07", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-08-02", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-06", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Odds Ratio of Airway Obstruction Relief Within One-Minute", "timeFrame"=>"1 minute", "description"=>"This outcome will be calculated using a mixed-effect logistic regression model, after assessment for group, carryover and period effect. Time will be calculated from when the participant first touches the mannequin to the time that the simulated food bolus is expelled from the mannequin's mouth. Comparison will be made between different pairs of devices."}], "secondaryOutcomes"=>[{"measure"=>"Odds Ratio of Airway Obstruction Relief Within Four-Minutes", "timeFrame"=>"4 minutes", "description"=>"This outcome will be calculated using a mixed-effect logistic regression model, after assessment for group, carryover and period effect. Time will be calculated from when the participant first touches the mannequin to the time that the simulated food bolus is expelled from the mannequin's mouth. Comparison will be made between different pairs of devices."}, {"measure"=>"Hazard Ratio of Time to Airway Obstruction Relief", "timeFrame"=>"Maximal time allotted is 4 minutes", "description"=>"This outcome will be calculated using a mixed-effect Cox regression model, after assessment for group, carryover and period effect. Time will be calculated from when the participant first touches the mannequin to the time that the simulated food bolus is expelled from the mannequin's mouth. Comparison will be made between different pairs of devices."}, {"measure"=>"Odds Ratio of Airway Obstruction Relief Within One-Minute (Retention Testing)", "timeFrame"=>"1 minute", "description"=>"This outcome will be calculated using a mixed-effect logistic regression model, after assessment for group, carryover and period effect. Time will be calculated from when the participant first touches the mannequin to the time that the simulated food bolus is expelled from the mannequin's mouth. Retention testing will occur between 90-120 days. Comparison will be made between different pairs of devices."}, {"measure"=>"Odds Ratio of Airway Obstruction Relief Within Four-Minutes (Retention Testing)", "timeFrame"=>"4 minutes", "description"=>"This outcome will be calculated using a mixed-effect logistic regression model, after assessment for group, carryover and period effect. Time will be calculated from when the participant first touches the mannequin to the time that the simulated food bolus is expelled from the mannequin's mouth. Retention testing will occur between 90-120 days. Comparison will be made between different pairs of devices."}, {"measure"=>"Hazard Ratio of Time to Airway Obstruction Relief (Retention Testing)", "timeFrame"=>"Maximal time allotted is 4 minutes", "description"=>"This outcome will be calculated using a mixed-effect Cox regression model, after assessment for group, carryover and period effect. Time will be calculated from when the participant first touches the mannequin to the time that the simulated food bolus is expelled from the mannequin's mouth. Participants will return for re-testing of skills between 90-120 days. Comparison will be made between different pairs of devices."}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Basic Life Support", "Foreign body airway obstruction", "Abdominal thrusts", "Layperson", "Airway Clearance Device", "Lifevac", "Dechoker"], "conditions"=>["Choking", "Airway Obstruction"]}, "descriptionModule"=>{"briefSummary"=>"WHY IS THIS STUDY BEING DONE? Little is known about the best treatment for choking. New airway clearance devices like LifeVac© and Dechoker© are being sold to help a choking person. Researchers do not know how well they work compared to other techniques like abdominal thrusts or back blows.\n\nThe purpose of this research study is to see how well bystanders can use the choking techniques.\n\nRESEARCH QUESTION Among laypersons, which FBAO intervention (abdominal thrusts, LifeVac©, or Dechoker©) results in the greatest proportion of FBAO relief within one-minute?\n\nPARTICIPANTS Adults aged 18 years or greater.\n\nINTERVENTIONS View a video of each choking intervention, and then complete a choking scenario where participants will try to relieve an airway obstruction on a simulation mannequin. The three interventions are: LifeVac, Dechoker, and Abdominal Thrusts. Participants will be invited back between 90-120 days to repeat the scenarios to assess retention.", "detailedDescription"=>"Foreign body airway obstructions (FBAO, choking) result in significant mortality and morbidity globally . If left untreated, individuals suffering from airway obstructions will progress to unresponsiveness and die. For the first time in decades, a novel choking intervention is being promoted. Airway clearance devices (such as LifeVac© or Dechoker©) are non-powered suction-based devices being marketed by manufacturers as a safer, easier alternative to traditional choking interventions. However, a systematic review, conducted by Dunne et al, demonstrated insufficient evidence to recommend their use in choking guidelines. Subsequently, a mannequin simulation trial by Patterson found LifeVac© to be superior to abdominal thrusts at FBAO relief within 4 minutes (odds ratio \\[OR\\] 47.32 \\[95%CI 5.74 - 389.40\\]), whereas Dechoker© was not (OR 1.22 \\[95% CI 0.60 - 2.47\\]). This study was only conducted in healthcare professionals, and the efficacy in laypersons is still unknown.\n\nStudy Objectives 1. To evaluate the relative efficacy of airway clearance devices compared to traditional interventions among laypersons.\n\nResearch Questions and Hypotheses\n\n1. Among laypersons, which FBAO intervention (abdominal thrusts, LifeVac©, or Dechoker©) results in the greatest proportion of FBAO relief within one-minutes?\n\nHypothesis: LifeVac© will relieve more FBAOs within one-minute compared to abdominal thrusts and Dechoker© based on a prior mannequin study among healthcare professionals.\n\nMethods Investigators will conduct an open-label, crossover, mannequin, randomized controlled trial to compare two ACDs (LifeVac© and Dechoker©) with traditional abdominal thrusts as FBAO interventions.\n\nRandomization: Using OnCore randomization service to 1 of 6 intervention orders. Randomization will be performed by a researcher not involved with participant recruitment, and allocation will be concealed until enrollment using OnCore software as well.\n\nPre-simulation: Prior to any intervention, each participant will receive an orientation to the simulator (Choking Charlie, Laerdal Medical AS, Stavanger, Norway), environment, and the outcomes being assessed. A member of the research team will be available to answer any questions that they have prior to starting.\n\nIntervention: Participants will be shown the manufacturer's (LifeVac© and Dechoker©) recommended short educational video for each intervention. A publicly available online instructional video, prepared by St John Ambulance, will be used for abdominal thrusts. Immediately after watching the first training video in their allocated sequence, participants will be asked to respond to a FBAO scenario, using the assigned technique. Participants will have up to four minutes to complete the intervention. All intervention attempts will be video recorded from a standardized position. Each participant will repeat the process (instructional video, followed by scenario) two more times so that they attempt each intervention. Participants will have a short break (of approximately two minutes) between each intervention.\n\nFollow Up: All participants will be invited back between 90 - 120 days to complete the same scenario with the 3 interventions again to assess skills retention."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged 18 years or older\n* Able to communicate in English (to sign informed consent)\n\nExclusion Criteria:\n\n- Physical disability limiting the performance/use of the interventions"}, "identificationModule"=>{"nctId"=>"NCT06227234", "briefTitle"=>"Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Calgary"}, "officialTitle"=>"Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation", "orgStudyIdInfo"=>{"id"=>"REB23-1548"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"LV - DC - AT", "description"=>"Order: LifeVac then Dechoker then Abdominal Thrusts", "interventionNames"=>["Other: Dechoker", "Other: LifeVac", "Other: Abdominal Thrusts"]}, {"type"=>"EXPERIMENTAL", "label"=>"LV - AT - DC", "description"=>"Order: LifeVac then Abdominal Thrusts then Dechoker", "interventionNames"=>["Other: Dechoker", "Other: LifeVac", "Other: Abdominal Thrusts"]}, {"type"=>"EXPERIMENTAL", "label"=>"DC - AT - LV", "description"=>"Order: Dechoker then Abdominal Thrusts then LifeVac", "interventionNames"=>["Other: Dechoker", "Other: LifeVac", "Other: Abdominal Thrusts"]}, {"type"=>"EXPERIMENTAL", "label"=>"DC - LV - AT", "description"=>"Order: Dechoker then LifeVac then Abdominal Thrusts", "interventionNames"=>["Other: Dechoker", "Other: LifeVac", "Other: Abdominal Thrusts"]}, {"type"=>"EXPERIMENTAL", "label"=>"AT - LV - DC", "description"=>"Order: Abdominal Thrusts then LifeVac then Dechoker", "interventionNames"=>["Other: Dechoker", "Other: LifeVac", "Other: Abdominal Thrusts"]}, {"type"=>"EXPERIMENTAL", "label"=>"AT - DC - LV", "description"=>"Order: Abdominal Thrusts then Dechoker then LifeVac", "interventionNames"=>["Other: Dechoker", "Other: LifeVac", "Other: Abdominal Thrusts"]}], "interventions"=>[{"name"=>"Dechoker", "type"=>"OTHER", "description"=>"Participants will be shown a short educational video for each intervention. A research assistant acting as an instructor will be present to answer any questions that the students have about each of the techniques.\n\nAfter training of all three techniques is complete, participants will be asked to respond to a choking scenario, using an assigned technique (the first one in their randomized order). Participants will use a mannequin (Choking Charlie, Laerdal Medical AS, Stavanger, Norway), with a simulated food bolus placed per manufacturer's directions, to complete each scenario. Participants will have up to four minutes to complete the intervention.\n\nEach participant will repeat the two more times so that they attempt each intervention.", "armGroupLabels"=>["AT - DC - LV", "AT - LV - DC", "DC - AT - LV", "DC - LV - AT", "LV - AT - DC", "LV - DC - AT"]}, {"name"=>"LifeVac", "type"=>"OTHER", "description"=>"Participants will be shown a short educational video for each intervention. A research assistant acting as an instructor will be present to answer any questions that the students have about each of the techniques.\n\nAfter training of all three techniques is complete, participants will be asked to respond to a choking scenario, using an assigned technique (the first one in their randomized order). Participants will use a mannequin (Choking Charlie, Laerdal Medical AS, Stavanger, Norway), with a simulated food bolus placed per manufacturer's directions, to complete each scenario. Participants will have up to four minutes to complete the intervention.\n\nEach participant will repeat the two more times so that they attempt each intervention.", "armGroupLabels"=>["AT - DC - LV", "AT - LV - DC", "DC - AT - LV", "DC - LV - AT", "LV - AT - DC", "LV - DC - AT"]}, {"name"=>"Abdominal Thrusts", "type"=>"OTHER", "description"=>"Participants will be shown a short educational video for each intervention. A research assistant acting as an instructor will be present to answer any questions that the students have about each of the techniques.\n\nAfter training of all three techniques is complete, participants will be asked to respond to a choking scenario, using an assigned technique (the first one in their randomized order). Participants will use a mannequin (Choking Charlie, Laerdal Medical AS, Stavanger, Norway), with a simulated food bolus placed per manufacturer's directions, to complete each scenario. Participants will have up to four minutes to complete the intervention.\n\nEach participant will repeat the two more times so that they attempt each intervention.", "armGroupLabels"=>["AT - DC - LV", "AT - LV - DC", "DC - AT - LV", "DC - LV - AT", "LV - AT - DC", "LV - DC - AT"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Cody Dunne, MD", "role"=>"CONTACT", "email"=>"cody.dunne@ucalgary.ca", "phone"=>"403.944.1818"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF"], "timeFrame"=>"Upon request.", "ipdSharing"=>"YES", "description"=>"Will be available upon request."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Calgary", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Canadian Association of Emergency Physicians", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
