PReventing the EffectS of Intubation on DEglutition

Mechanical Ventilation Complication Clinical Trial

— PRESIDE  

Official title:

Understanding and Improving Dysphagia After Mechanical Ventilation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02442102
• Other study ID #: IRB00029289
• Secondary ID: 1K23DC013569-01
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: August 2022

Study information

• Verified date: December 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Ventilation Therapy
• Deglutition Disorders
• Mechanical Ventilation Complication

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants aspirating during fiberoptic endoscopic swallow study		participants will be evaluated an expected average of 48 hours after extubation