PReventing the EffectS of Intubation on DEglutition

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.

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