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PReventing the EffectS of Intubation on DEglutition (PRESIDE)

This study is currently recruiting participants.
Verified February 2017 by Martin B. Brodsky, PhD, ScM, Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02442102
First Posted: May 13, 2015
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Martin B. Brodsky, PhD, ScM, Johns Hopkins University
  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.

Condition Intervention Phase
Deglutition Disorders Mechanical Ventilation Complication Complication of Ventilation Therapy Behavioral: Exercise and sensory stimulation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Understanding and Improving Dysphagia After Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Martin B. Brodsky, PhD, ScM, Johns Hopkins University:

Primary Outcome Measures:
  • Number of participants aspirating during videofluoroscopic swallow study [ Time Frame: participants will be evaluated an expected average of 48 hours after extubation ]

Estimated Enrollment: 40
Study Start Date: July 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise and sensory stimulation
60-minute sessions with sensory electrical stimulation (SES) applied 5 days per week with oromotor exercises completed when patient is able to participate
Behavioral: Exercise and sensory stimulation
60-minute sessions with sensory electrical stimulation (SES) applied 5 days per week with oromotor exercises completed when patient is able to participate
Other Name: VitalStim (Chattanooga Group; Hixson, TN)

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442102


Contacts
Contact: Martin B Brodsky, PhD, ScM (410) 502-2441 mbbrodsky@jhmi.edu
Contact: Dale M Needham, MD, PhD (410) 955-3467 dale.needham@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Martin B. Brodsky, PhD, ScM    410-502-2441    mbbrodsky@jhmi.edu   
Principal Investigator: Martin B. Brodsky, PhD, ScM         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Martin B Brodsky, PhD, ScM Johns Hopkins University
  More Information

Publications:

Responsible Party: Martin B. Brodsky, PhD, ScM, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02442102     History of Changes
Other Study ID Numbers: K23DC013569 ( U.S. NIH Grant/Contract )
1K23DC013569-01 ( U.S. NIH Grant/Contract )
First Submitted: May 4, 2015
First Posted: May 13, 2015
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Martin B. Brodsky, PhD, ScM, Johns Hopkins University:
deglutition disorders
therapeutics
rehabilitation
outcome assessment
intubation
critical care
larynx
voice

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases