Baltimore, Maryland 21287


Purpose:

An early intervention for swallowing disorders (i.e., dysphagia) during endotracheal intubation may improve patient outcomes. The investigators propose treatment sessions targeting sensorimotor integration, strength, and range of motion during oral endotracheal intubation with mechanical ventilation to reduce or prevent dysphagia and aspiration (food or liquids entering the airway), establish a solid foundation in understanding reasons for swallowing impairment after extubation from mechanical ventilation and learn new methods to reduce or prevent these problems.


Study summary:

The overall goals of this study are to evaluate patients with acute respiratory failure from the time they are orally intubated in the ICU to: 1) investigate tongue weakness and other pathophysiological aspects of dysphagia, and 2) evaluate, in a Phase II clinical trial, a novel, multimodal, sensorimotor intervention conducted during intubation to reduce or prevent dysphagia after extubation. Patients who are expected to be intubated with mechanical ventilation for >96 hours will be consecutively enrolled shortly after intubation. Laryngeal function, tongue strength, swallowing pathophysiology, and breathing-swallowing coordination will be evaluated with valid and reliable standardized measures. While orally intubated, patients in the treatment group will receive a novel, early, sensorimotor intervention for 60-minutes daily, 5 times per week, targeting improved swallowing physiology and kinematics to reduce aspiration and dysphagia. These daily sessions will continue until the completion of a modified barium swallow study conducted within approximately 2 days after extubation, and thereafter standard clinical care will resume. Patients in the control group will receive standard clinical care during intubation and throughout their hospital stay. All patients will be followed to hospital discharge to determine the pathophysiological and clinical impact of the proposed intervention. Knowledge from this study will provide important data for this novel intervention and provide a critical foundation for understanding the physiological mechanisms of dysphagia and aspiration after intubation in patients with acute respiratory failure. With success, this investigation will help shift clinical practice patterns to consider early intervention with the goal of reducing the frequency and severity of swallowing impairment leading to aspiration and additional medical complications.


Criteria:

Inclusion Criteria: 1. ≥21 years old 2. Required mechanical ventilation via an oral endotracheal tube Exclusion Criteria: 1. Unable to understand or speak English due to a language barrier 2. Unable to understand or speak English due to a cognitive impairment 3. Barium sulfate allergy 4. Pregnancy 5. Presence of any cardiac pacing device (including temporary epicardial pacing) without an underlying cardiac rhythm as confirmed by treating physician or diaphragmatic pacer 6. Nasal endotracheal intubation during the present admission 7. Patient is not expected to require ≥48 hours of intubation 8. Pre-existing dysphagia/aspiration, voice or cognitive disorder 9. Reflux with history of known or suspected aspiration 10. Presence of a central nervous system, neuromuscular or connective tissue disease (e.g., stroke, Guillain-Barre, scleroderma) 11. Active seizure disorder 12. Pain disorder of the jaw muscles or mandibular joint 13. Ever tracheotomy or prior endotracheal intubation other than for surgery (≤ 1 year) 14. Head and/or neck disease (e.g., oropharyngeal cancer) 15. Head and/or neck surgery other than tonsillectomy 16. Known or suspected anatomical abnormalities or pre-intubation trauma of the oral cavity, pharynx, larynx, or esophagus 17. Known or suspected sleep apnea (treated or untreated) 18. Prior major thoracic surgery (e.g., sternotomy, thoracotomy) 19. Unplanned (e.g., self- or accidental) extubation or re-intubation before consent 20. Weight exceeds capacity of the radiology equipment 21. Expected tracheostomy tube placement while in hospital 22. Moribund (>90% probability of mortality in hospital), based on ICU team's assessment


NCT ID:

NCT02442102


Primary Contact:

Principal Investigator
Martin B Brodsky, PhD, ScM
Johns Hopkins University

Martin B Brodsky, PhD, ScM
Phone: (410) 502-2441
Email: mbbrodsky@jhmi.edu


Backup Contact:

Email: dale.needham@jhmi.edu
Dale M Needham, MD, PhD
Phone: (410) 955-3467


Location Contact:

Baltimore, Maryland 21287
United States

Martin B. Brodsky, PhD, ScM
Phone: 410-502-2441
Email: mbbrodsky@jhmi.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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