PRESIDE: PReventing the EffectS of Intubation on DEglutition

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02442102

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Understanding and Improving Dysphagia After Mechanical Ventilation

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Number of participants aspirating during fiberoptic endoscopic swallow study [participants will be evaluated an expected average of 48 hours after extubation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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