[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447627":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":126,"collaborators":128,"id":132,"slug":34,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":9,"acronym":34,"eligibilityCriteria":136,"healthyVolunteers":133,"sex":137,"minAge":138,"maxAge":34,"enrollmentInfo":139,"targetDuration":34,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":34,"overallStatus":48,"whyStopped":34,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Aspiration in Acute Respiratory Failure Survivors","All participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam.",[12,13,14],"Diagnostic Test: 3-Screenings Protocol","Diagnostic Test: FEES","Diagnostic Test: Tracheal Ultrasound",[16,24,30],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","3-Screenings Protocol","The 3-Screenings Protocol is a modified bedside swallow exam (BSE) consisting of a study developed five-item decision tree algorithm including voice quality assessment and a 2-ounce water consistency assessment, the Yale Swallow Test, with a scored 3-ounce Water Swallow Test (3-WST), and the Toronto Bedside Swallowing Screening Test (TOR-BSST).",[9],[22,23],"Modified bedside swallow exam (BSE)","Three Screening Tests",{"type":17,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"FEES","A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and\u002For oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.",[9],[29],"Fiberoptic Endoscopic Evaluation of Swallowing",{"type":17,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Tracheal Ultrasound","Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation",[9],null,[36],{"name":37,"affiliation":5,"role":38},"Marc Moss, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},"Jeff McKeehan, RN,MSN","CONTACT","3037246080","jeffrey.mckeehan@cuanschutz.edu",[46,64,83,98,113],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Stanford Univerity","RECRUITING","Stanford","California","94305","United States",{"type":54,"coordinates":55},"Point",[56,57],-122.16608,37.42411,{"lat":57,"lon":56},[60,63],{"name":61,"role":42,"phone":34,"phoneExt":34,"email":62},"Joseph Levitt, MD, MS","JLevitt@stanford.edu",{"name":61,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":65,"status":48,"city":66,"state":67,"zip":68,"country":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University of Colorado","Aurora","Colorado","80045",{"type":54,"coordinates":70},[71,72],-104.83192,39.72943,{"lat":72,"lon":71},[75,79,82],{"name":76,"role":42,"phone":77,"phoneExt":34,"email":78},"Anna Matheson, RN, BSN","303-724-6377","anna.matheson@cuanschutz.edu",{"name":80,"role":42,"phone":43,"phoneExt":34,"email":81},"Jeffrey McKeehan, RN, MSN","Jeffrey.McKeehan@cuanschutz.edu",{"name":37,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":84,"status":48,"city":85,"state":86,"zip":87,"country":52,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Yale University","New Haven","Connecticut","06519",{"type":54,"coordinates":89},[90,91],-72.92816,41.30815,{"lat":91,"lon":90},[94,97],{"name":95,"role":42,"phone":34,"phoneExt":34,"email":96},"Jonathan Siner, MD","Jonathan.Siner@yale.edu",{"name":95,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":99,"status":48,"city":100,"state":101,"zip":102,"country":52,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Tufts Medical Center","Boston","Massachusetts","02111",{"type":54,"coordinates":104},[105,106],-71.05977,42.35843,{"lat":106,"lon":105},[109,112],{"name":110,"role":42,"phone":34,"phoneExt":34,"email":111},"Nicholas Hill, MD","nicholas.hill@tuftsmedicine.org",{"name":110,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":114,"status":48,"city":100,"state":101,"zip":115,"country":52,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"Boston University","02118",{"type":54,"coordinates":117},[105,106],{"lat":106,"lon":105},[120,123,124],{"name":121,"role":42,"phone":34,"phoneExt":34,"email":122},"Gintas Krisciunas, MPH, MS","Gintas.Krisciunas@bmc.org",{"name":121,"role":38,"phone":34,"phoneExt":34,"email":34},{"name":125,"role":38,"phone":34,"phoneExt":34,"email":34},"Susan Langmore, PhD",{"type":127,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[129],{"name":130,"class":131},"National Institute of Nursing Research (NINR)","NIH","100447627",false,"NCT05108896","Aspiration in Acute Respiratory Failure Survivors 2","Inclusion Criteria:\n\n1. Admission to an ICU.\n2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.\n\nExclusion Criteria:\n\n1. Likely persistent contraindications to enteral\u002Foral nutrition administration.\n2. Pre-existing history of dysphagia or aspiration.\n3. Pre-existing or acute primary central or peripheral neuromuscular disorder.\n4. Presence of a chronic tracheostomy (present prior to ICU admission).\n5. Pre-existing head and neck cancer or surgery.\n6. Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.\n7. Delirium for more than 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).\n8. Extubated for greater than 96 hours.\n9. Inability to obtain informed consent from patient or an appropriate surrogate.\n10. Age \\\u003C 18 years.","ALL","18 Years",{"count":140,"type":141},855,"ESTIMATED","INTERVENTIONAL",[144],"NA","The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.",[147,148],"Dysphagia","Aspiration","2024-10-07",{"date":151,"type":152},"2024-10-08","ACTUAL",{"date":154,"type":152},"2021-12-15",{"date":156,"type":141},"2025-12-15",{"name":5,"class":6},5]