[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649528":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":61,"collaborators":30,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":30,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":30,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":90,"whyStopped":30,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Expiratory muscle strength training (EMST)","EXPERIMENTAL","Critically ill adults will complete EMST as prescribed.",[13],"Behavioral: Expiratory muscle strength training (EMST)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Dysphagia Treatment","ACTIVE_COMPARATOR","Critically ill adults will receive dysphagia treatment per standard of care.",[19],"Behavioral: Standard of Care Dysphagia Treatment",{"label":21,"type":10,"description":22,"interventionNames":23},"Intensive Dysphagia Treatment","Critically ill adults will complete intensive dysphagia treatment as prescribed.",[24],"Behavioral: Intensive Dysphagia Treatment",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","EMST devices will be set to 60% of participants' maximum expiratory pressure. Participants will complete training 5 days per week by performing 5 sets of 5 repetitions.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Critically ill adults will perform one set of ten repetitions of each exercise recommended by their clinical speech-language pathologist. Enrolled participants will complete up to two training sessions per week (0-2 pending normal clinical care course) with a clinical speech-language pathologist",[15],{"type":27,"name":21,"description":35,"armGroupLabels":36,"otherNames":30},"Critically ill adults will perform one set of ten repetitions of each exercise (effortful swallow, Masako maneuver, Mendelsohn maneuver, chin tuck against resistance, tongue strengthening exercises, and may also participate in bolus driven therapy). Enrolled participants will complete five training sessions per week (at least 3 days\u002Fweek with the PI or a trained member of the research team and up to 2 days\u002Fweek with a member of the clinical speech-language pathology team).",[21],[38],{"name":39,"affiliation":5,"role":40},"Cara Donohue, PhD CCC-SLP","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},"CONTACT","615-852-5085","cara.donohue@vumc.org",[47],{"facility":5,"status":30,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Nashville","Tennessee","37232","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.78444,36.16589,{"lat":57,"lon":56},[60],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},{"type":40,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Cara Donohue, Ph.D. CCC-SLP","Assistant Professor, Director of Medical Speech-Language Pathology","100649528","optimizing-dysphagia-treatment-delivery-in-acute-care-a-hybrid-efficacy-implementation-trial-100649528",false,"NCT07736105","Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial","Inclusion criteria for critically ill adults will be:\n\n1. Adult ≥ 18 years old\n2. Not pregnant\n3. Underwent a clinical flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopy swallow study (VFSS) with a penetration aspiration scale (PAS) score ≥ 5\n4. Hospitalized in non-neuro intensive care unit (ICU) setting at Vanderbilt University Medical Center (VUMC) at some point during admission\n5. Dysphagia is primarily related to ICU stay and not other medical conditions that may cause dysphagia\n6. medically cleared with no contraindications for expiratory muscle strength training (EMST) or other treatments\n7. Cognitive capacity to follow basic directions\n8. Willing to undergo testing and treatment for the study.\n\nInclusion criteria for speech-language pathologists (SLPs) will be:\n\n1. Adult acute care speech-language pathologist who works at VUMC.\n2. Willing to complete surveys and\u002For participate in a focus group.","ALL","18 Years",{"count":73,"type":74},120,"ESTIMATED","INTERVENTIONAL",[77],"NA","This research study is investigating the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Currently, no targeted, effective, and feasible dysphagia treatment approaches currently exist for use in critically ill adults in the acute care setting. The current study will investigate the impact of EMST, standard of care dysphagia treatment, and intensive dysphagia treatment on pulmonary function, cough function, swallow function, frailty, patient-reported swallow function, and health outcomes in critically ill adults. This study will also examine patient perceptions and clinical speech-language pathologists' perceptions of the acceptability, appropriateness, and feasibility of these interventions.\n\nCritically ill adults will: undergo tests of breathing, cough, and swallow function, complete questionnaires about the treatment, and their swallow function, and complete their respective treatment as prescribed.\n\nClinical speech-language pathologists will complete questionnaires about the interventions.\n\nA subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.",[80,81],"Dysphagia","Critical Illness",[80,83,84,85,86,87,88,81,89],"Swallowing","Deglutition","Deglutition Disorders","Swallowing Disorders","Breathing","Cough","Treatment","NOT_YET_RECRUITING","2026-07-29",{"date":93,"type":94},"2026-07-30","ACTUAL",{"date":96,"type":74},"2027-04",{"date":98,"type":74},"2029-02",{"name":5,"class":6},1]