Understanding and Improving Dysphagia after Mechanical Ventilation

了解和改善机械通气后吞咽困难

基本信息

批准号：
8617042
负责人：
Martin Bruce Brodsky
金额：
$ 21.08万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-01 至 2018-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8617042
关键词：
Abnormal coordination Acute Acute respiratory failure Address Affect Age American Animal Model Articular Range of Motion Aspiration Pneumonia Barium swallow Breathing Cervical Cessation of life Chronic Clinical Clinical Practice Patterns Clinical Research Clinical Trials Control Groups Data Deglutition Deglutition Disorders Early Intervention Elderly Enrollment Esthesia Evaluation Exercise Female Foundations Frequencies Functional disorder Future Goals Grant Healthcare Hospitals Hour Impairment Intensive Care Units Intervention Intratracheal Intubation Intubation Investigation Iowa Knowledge Laryngeal Injury Laryngoscopy Larynx Lead Length of Stay Massage Mechanical ventilation Mechanics Mediating Mentored Patient-Oriented Research Career Development Award Mentors Morbidity - disease rate Motor Muscle Weakness Nature Oral Oropharyngeal Outcome Patients Pattern Penetration Performance Pharyngeal structure Phase Phase I Clinical Trials Physical Rehabilitation Physical therapy exercises Physiological Physiology Principal Investigator Randomized Controlled Trials Recruitment Activity Rehabilitation therapy Research Research Methodology Risk Risk Factors Sampling Sedation procedure Sensory Severities Solid Stroke Time Tongue Tracheostomy procedure Training United States National Institutes of Health clinical care experience improved instrument kinematics lung injury medical complication multi-component intervention muscle form muscle strength novel patient oriented research patient population prevent public health relevance sex standardize measure success

项目摘要

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：每年，近 100 万美国人经历急性呼吸衰竭（ARF），需要在重症监护室（ICU）接受机械通气。现有证据表明，经口气管插管与导致误吸的吞咽障碍（即吞咽困难）之间存在密切关联，吞咽障碍是由喉部损伤、口咽肌无力、喉部感觉减弱和呼吸吞咽协调障碍等综合因素介导的。了解这些问题对于预防和治疗该患者群体的吞咽困难至关重要。拔管后，高达 83% 的患者会出现吞咽困难，与中风患者相比，他们患吸入性肺炎的风险增加 6 倍，死亡风险增加 3 倍。如果不进行干预，在 ICU 的 ARF 期间会出现相当大的肌肉无力和身体损伤，但最近的试验表明，机械通气期间较少的镇静结合早期身体康复可以改善这些损伤。同样，对气管插管期间吞咽困难的早期干预可能会改善患者的预后。本研究的总体目标是从 ARF 患者在 ICU 经口插管时起对其进行评估，以：1）调查舌无力和吞咽困难的其他病理生理学方面，2）在 I 期临床试验中评估一种新型的、插管期间进行多模式感觉运动干预，以减少拔管后的吞咽困难。该 K23 奖项还旨在通过以下方式为首席研究员提供独立进行以患者为导向的研究所需的背景：1）以临床试验为重点的临床研究方法高级方面的培训； 2) 为开展专注于改善患者治疗效果的 I 期临床试验提供指导性研究经验。预计机械通气插管时间>96小时的患者将在插管后不久连续入组。将通过有效且可靠的标准化措施来评估喉功能、舌头力量、吞咽病理生理学和呼吸吞咽协调。在经口插管时，治疗组的患者将每天接受 60 分钟的新颖、早期感觉运动干预，旨在改善吞咽生理和运动学，以减少误吸和吞咽困难。这些每日治疗将持续进行，直到完成拔管后 48 小时内进行的改良吞钡研究，此后将恢复标准临床护理。对照组患者将在治疗期间接受标准临床护理插管期间和整个住院期间。所有受试者出院后均将被跟踪以确定所提议的干预措施的病理生理学和临床影响。这项研究的知识将为新型药物提供重要的可行性数据和初步疗效数据干预并为了解 ARF 患者插管后吞咽困难和误吸的生理机制提供重要基础。