PReventing the EffectS of Intubation on DEglutition (PRESIDE)

January 9, 2023 updated by: Johns Hopkins University

Understanding and Improving Dysphagia After Mechanical Ventilation

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • VitalStim (Chattanooga Group; Hixson, TN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants aspirating during fiberoptic endoscopic swallow study
Time Frame: participants will be evaluated an expected average of 48 hours after extubation
participants will be evaluated an expected average of 48 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Dale M Needham, MD PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00029289
  • 1K23DC013569-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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