Annually, nearly 1 million Americans experience acute respiratory failure (ARF) requiring mechanical ventilation in intensive care units (ICU). Existing evidence demonstrates a strong association between oral endotracheal intubation and swallowing impairment (i.e., dysphagia) leading to aspiration, mediated by a combination of factors such as laryngeal injury, oropharyngeal muscle weakness, reduced laryngeal sensation, and breathing-swallowing dyscoordination. Understanding these issues is central to preventing and treating dysphagia in this patient population. After extubation, dysphagia affects up to 83% of patients and predisposes them to a 6-fold increased risk of aspiration pneumonia and a 3-fold increased risk of death compared with stroke patients. Without intervention, considerable muscle weakness and physical impairment occurs during ARF in the ICU, but recent trials demonstrate that less sedation combined with early physical rehabilitation during mechanical ventilation improve these impairments. Similarly, an early intervention for dysphagia during endotracheal intubation may improve patient outcomes. The overall goals of this study are to evaluate ARF patients 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 I clinical trial, a novel, multimodal, sensorimotor intervention conducted during intubation to reduce dysphagia after extubation. This K23 award also aims to provide the Principal Investigator with the background necessary to become independent in patient-oriented research by: 1) training in advanced aspects of clinical research methods with a focus on clinical trials;and 2) providing a mentored research experience for conducting this Phase I clinical trial focused on improving patient outcomes. 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, 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 48 hours 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 subjects will be followed to hospital discharge to determine the pathophysiological and clinical impact of the proposed intervention. Knowledge from this study will provide important feasibility data and preliminary efficacy data for the novel intervention and provide a critical foundation for understanding the physiological mechanisms of dysphagia and aspiration after intubation in ARF patients.

Public Health Relevance

Advances in health care have led to increasing numbers of patients surviving acute respiratory failure, often with serious post-ICU morbidities, including swallowing impairment. This investigation aims to establish a solid foundation in understanding reasons for swallowing impairment after extubation from mechanical ventilation and new ways to reduce these problems. 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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
1K23DC013569-01
Application #
8617042
Study Section
Communication Disorders Review Committee (CDRC)
Program Officer
Sklare, Dan
Project Start
2014-05-01
Project End
2018-04-30
Budget Start
2014-05-01
Budget End
2015-04-30
Support Year
1
Fiscal Year
2014
Total Cost
$210,753
Indirect Cost
$13,241
Name
Johns Hopkins University
Department
Physical Medicine & Rehab
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218