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NCT Number: NCT07736105

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location contact

Cara Donohue, PhD CCC-SLP

CONTACT

[email protected]

615-852-5085

About this study

This study will involve two in-person research evaluations in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, measures of frailty, and completion of questionnaires. Following the initial research evaluation, critically ill adults will complete the intervention they are assigned to as prescribed. The exercises will take 15-20 minutes to complete and adherence to treatment will be tracked. Prior to hospital discharge and after completion of the intervention, critically ill adults will undergo a second research evaluation.

Clinical speech-language pathologists will complete questionnaires about the interventions that will take 10-15 minutes.

A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups, which will take 45 minutes-1 hour.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for critically ill adults will be:

  • Adult ≥ 18 years old
  • Not pregnant
  • Underwent a clinical flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopy swallow study (VFSS) with a penetration aspiration scale (PAS) score ≥ 5
  • Hospitalized in non-neuro intensive care unit (ICU) setting at Vanderbilt University Medical Center (VUMC) at some point during admission
  • Dysphagia is primarily related to ICU stay and not other medical conditions that may cause dysphagia
  • medically cleared with no contraindications for expiratory muscle strength training (EMST) or other treatments
  • Cognitive capacity to follow basic directions
  • Willing to undergo testing and treatment for the study.

Inclusion criteria

for speech-language pathologists (SLPs) will be:

  • Adult acute care speech-language pathologist who works at VUMC.
  • Willing to complete surveys and/or participate in a focus group.

Treatment and study plan

Expiratory muscle strength training (EMST)

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.

Standard of Care Dysphagia Treatment

Behavioral

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

Intensive Dysphagia Treatment

Behavioral

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).

Primary outcomes

  1. Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades

    Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

    The DIGEST is a validated, 5-point ordinal rating scale that quantifies global pharyngeal swallow function.

  2. Change in Penetration Aspiration Scale Scores

    Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

    The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score).

Secondary outcomes

  1. Change in maximum expiratory pressure

    Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

    A measure of respiratory strength while breathing out

  2. Change in cough peak expiratory flow

    Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

    A measure of cough strength

  3. Grip strength

    Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

    Change in Grip strength be used to quantify clinical frailty using a digital hand dynamometer.

  4. Change in Swallowing and Eating Related Fatigue Questionnaire (SERF)

    Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

    Scores on the SERF range 0-48 with higher scores indicating greater impairment.

  5. Change in Screening for Oral Frailty Tool (SOFT)

    Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

    Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.

  6. Change in Eating Assessment Tool 10 (EAT-10)

    Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

    The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.

  7. Acceptability of Intervention Measure (AIM)

    Time frame: post-treatment prior to hospital discharge, assessed up to 2 weeks

    A measure of how acceptable an intervention is with scores ranging from 4-20.

  8. Intervention Appropriateness Measure (IAM)

    Time frame: post-treatment prior to hospital discharge, assessed up to 2 weeks

    A measure of how appropriate an intervention is with scores ranging from 4-20.

  9. Feasibility of Intervention Measure (FIM)

    Time frame: post-treatment prior to hospital discharge, assessed up to 2 weeks

    A measure of how feasible an intervention is with scores ranging from 4-20.

Study contacts

Contact information is provided by the study sponsor or research team.

Cara Donohue, PhD CCC-SLP

CONTACT

[email protected]

615-852-5085

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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