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NOT YET RECRUITING
NCT07736105
NA

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

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2027-04

Completion Date

2029-02

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

BEHAVIORAL

Expiratory muscle strength training (EMST)

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.

BEHAVIORAL

Standard of Care Dysphagia Treatment

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

BEHAVIORAL

Intensive Dysphagia Treatment

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/week with the PI or a trained member of the research team and up to 2 days/week with a member of the clinical speech-language pathology team).

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States