[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534262":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":42,"centralContacts":50,"locations":55,"responsibleParty":89,"collaborators":28,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":28,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":123,"whyStopped":28,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Automated tracheostomy suctioning device","EXPERIMENTAL","Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device.",[13],"Device: NextGen automated tracheostomy suctioning device",{"label":15,"type":10,"description":16,"interventionNames":17},"Mixed-reality tracheostomy tube change system","Participants in this group will receive tracheostomy tube changes using a mixed-reality tracheostomy tube change device.",[18],"Device: NextGen mixed-reality tracheostomy tube change system",{"label":20,"type":10,"description":21,"interventionNames":22},"NextGen Tracheostomy Toolkit","Participants in this group will receive tracheostomy care using the NextGen Tracheostomy Toolkit. Providers will be trained using virtual reality educational modules. Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device and tracheostomy tube changes using a mixed-reality tracheostomy tube change device.",[23],"Device: NextGen Tracheostomy Toolkit",{"label":25,"type":26,"description":27,"interventionNames":28},"Control group","NO_INTERVENTION","Participants in this group will receive usual tracheostomy care.",null,[30,35,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":28},"DEVICE","NextGen automated tracheostomy suctioning device","Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctionings using an automated robotic suctioning device.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":28},"NextGen mixed-reality tracheostomy tube change system","Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy tube changes using the mixed reality tracheostomy tube change system.",[15],{"type":31,"name":20,"description":40,"armGroupLabels":41,"otherNames":28},"Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctioning using the robotic suctioning device; and tracheostomy tube changes using the mixed reality tracheostomy tube change system.",[20],[43,47],{"name":44,"affiliation":45,"role":46},"Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC","Johns Hopkins University School of Nursing","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":49,"role":46},"Michael J Brenner, MD, FACS","University of Michigan",[51],{"name":44,"role":52,"phone":53,"phoneExt":28,"email":54},"CONTACT","443-655-3482","vpandia1@jhu.edu",[56,75],{"facility":5,"status":28,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Baltimore","Maryland","21205","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-76.61219,39.29038,{"lat":66,"lon":65},[69,70,73],{"name":44,"role":52,"phone":53,"phoneExt":28,"email":54},{"name":71,"role":72,"phone":28,"phoneExt":28,"email":28},"Axel Mathias, PhD","SUB_INVESTIGATOR",{"name":74,"role":72,"phone":28,"phoneExt":28,"email":28},"Mathias Unberath, PhD",{"facility":49,"status":28,"city":76,"state":77,"zip":78,"country":60,"countryCode":61,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Ann Arbor","Michigan","48104",{"type":63,"coordinates":80},[81,82],-83.74088,42.27756,{"lat":82,"lon":81},[85,88],{"name":48,"role":52,"phone":86,"phoneExt":28,"email":87},"734-369-0204","mbren@med.umich.edu",{"name":48,"role":46,"phone":28,"phoneExt":28,"email":28},{"type":90,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100534262","tracheostomy-robotics-and-cutting-edge-health-education-for-airway-safety-100534262",false,"NCT06236542","Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety","NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care","TRACHEAS","Inclusion Criteria:\n\n* adult patients 18 years or older\n* those who received a tracheostomy during their hospital stay\n* those who were admitted to the hospital with a tracheostomy\n\nExclusion Criteria:\n\n* none",true,"ALL","18 Years","100 Years",{"count":104,"type":105},632,"ESTIMATED","INTERVENTIONAL",[108],"NA","The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are:\n\n* What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group?\n* What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group?\n* What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group?\n* What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions.\n\n  1. Experimental group 1 will receive suctionings using automated robotic suctioning device.\n  2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system.\n  3. Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system.\n  4. Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.",[111],"Tracheostomy",[111,113,114,115,116,117,118,119,120,121,122],"Tracheostomy education","Immersive learning","Simulation","Virtual reality","Mixed reality","Robotics","Tracheostomy suctioning","Tracheostomy tube change","Patient safety","Critical care","NOT_YET_RECRUITING","2024-01-24",{"date":126,"type":127},"2024-02-01","ACTUAL",{"date":129,"type":105},"2027-10-01",{"date":131,"type":105},"2029-09-30",{"name":5,"class":6},2]