PReventing the EffectS of Intubation on DEglutition (PRESIDE)

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. Identifier: NCT02442102
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : January 7, 2019
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Deglutition Disorders Mechanical Ventilation Complication Complication of Ventilation Therapy Behavioral: Exercise and sensory stimulation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Understanding and Improving Dysphagia After Mechanical Ventilation
Study Start Date : July 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ≥18 years old
  • Required mechanical ventilation via an oral endotracheal tube

Exclusion Criteria:

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

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 identifier (NCT number): NCT02442102

Contact: Martin B Brodsky, PhD, ScM (410) 502-2441
Contact: Dale M Needham, MD, PhD (410) 955-3467

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


Responsible Party: Johns Hopkins University Identifier: NCT02442102     History of Changes
Other Study ID Numbers: IRB00029289
1K23DC013569-01 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Keywords provided by Johns Hopkins University:
deglutition disorders
outcome assessment
critical care

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