[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447627":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":127,"collaborators":129,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":9,"acronym":34,"eligibilityCriteria":138,"healthyVolunteers":135,"sex":139,"minAge":140,"maxAge":34,"enrollmentInfo":141,"targetDuration":34,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":34,"overallStatus":48,"whyStopped":34,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"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",[46,65,84,99,114],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Stanford Univerity","RECRUITING","Stanford","California","94305","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.16608,37.42411,{"lat":58,"lon":57},[61,64],{"name":62,"role":42,"phone":34,"phoneExt":34,"email":63},"Joseph Levitt, MD, MS","JLevitt@stanford.edu",{"name":62,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":66,"status":48,"city":67,"state":68,"zip":69,"country":52,"countryCode":53,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of Colorado","Aurora","Colorado","80045",{"type":55,"coordinates":71},[72,73],-104.83192,39.72943,{"lat":73,"lon":72},[76,80,83],{"name":77,"role":42,"phone":78,"phoneExt":34,"email":79},"Anna Matheson, RN, BSN","303-724-6377","anna.matheson@cuanschutz.edu",{"name":81,"role":42,"phone":43,"phoneExt":34,"email":82},"Jeffrey McKeehan, RN, MSN","Jeffrey.McKeehan@cuanschutz.edu",{"name":37,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":85,"status":48,"city":86,"state":87,"zip":88,"country":52,"countryCode":53,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Yale University","New Haven","Connecticut","06519",{"type":55,"coordinates":90},[91,92],-72.92816,41.30815,{"lat":92,"lon":91},[95,98],{"name":96,"role":42,"phone":34,"phoneExt":34,"email":97},"Jonathan Siner, MD","Jonathan.Siner@yale.edu",{"name":96,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":100,"status":48,"city":101,"state":102,"zip":103,"country":52,"countryCode":53,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Tufts Medical Center","Boston","Massachusetts","02111",{"type":55,"coordinates":105},[106,107],-71.05977,42.35843,{"lat":107,"lon":106},[110,113],{"name":111,"role":42,"phone":34,"phoneExt":34,"email":112},"Nicholas Hill, MD","nicholas.hill@tuftsmedicine.org",{"name":111,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":115,"status":48,"city":101,"state":102,"zip":116,"country":52,"countryCode":53,"cosmosGeoPoint":117,"geoPoint":119,"contacts":120},"Boston University","02118",{"type":55,"coordinates":118},[106,107],{"lat":107,"lon":106},[121,124,125],{"name":122,"role":42,"phone":34,"phoneExt":34,"email":123},"Gintas Krisciunas, MPH, MS","Gintas.Krisciunas@bmc.org",{"name":122,"role":38,"phone":34,"phoneExt":34,"email":34},{"name":126,"role":38,"phone":34,"phoneExt":34,"email":34},"Susan Langmore, PhD",{"type":128,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[130],{"name":131,"class":132},"National Institute of Nursing Research (NINR)","NIH","100447627","aspiration-in-acute-respiratory-failure-survivors-2-100447627",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":142,"type":143},855,"ESTIMATED","INTERVENTIONAL",[146],"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.",[149,150],"Dysphagia","Aspiration","2024-10-07",{"date":153,"type":154},"2024-10-08","ACTUAL",{"date":156,"type":154},"2021-12-15",{"date":158,"type":143},"2025-12-15",{"name":5,"class":6},5]