NCT02442102

PReventing the EffectS of Intubation on DEglutition

Understanding and Improving Dysphagia After Mechanical Ventilation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2015-05-13
• Last updated: 2023-01-10

Locations

1 site across 1 country: United States