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Not Yet Recruiting NCT07736105

Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial

Conditions: Dysphagia, Critical Illness

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Vanderbilt University Medical Center

Location: Vanderbilt University Medical Center Nashville Tennessee

Summary

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. Critically 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. Clinical speech-language pathologists will complete questionnaires about the interventions. A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.

Eligibility Criteria

Inclusion criteria for critically ill adults will be: 1. Adult ≥ 18 years old 2. Not pregnant 3. Underwent a clinical flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopy swallow study (VFSS) with a penetration aspiration scale (PAS) score ≥ 5 4. Hospitalized in non-neuro intensive care unit (ICU) setting at Vanderbilt University Medical Center (VUMC) at some point during admission 5. Dysphagia is primarily related to ICU stay and not other medical conditions that may cause dysphagia 6. medically cleared with no contraindications for expiratory muscle strength training (EMST) or other treatments 7. Cognitive capacity to follow basic directions 8. Willing to undergo testing and treatment for the study. Inclusion criteria for speech-language pathologists (SLPs) will be: 1. Adult acute care speech-language pathologist who works at VUMC. 2. Willing to complete surveys and/or participate in a focus group.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07736105). StuddyBuddy aggregates publicly available trial information.