Improving Recovery in Older ICU Survivors: Evaluation of Swallowing Dysfunction and Aspiration Risk
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Swallowing safety and efficiency
研究概览
简要总结
Post-intensive care syndrome (PICS), which consists of physical, cognitive, and psychosocial problems, is a pervasive complication for older intensive care unit (ICU) survivors and contributes to detrimental health outcomes and significant reductions in quality of life. Yet, little is known about the relationship between PICS, swallowing difficulties (dysphagia), and other ICU-related negative outcomes such as frailty and Alzheimer's Disease and Related Dementias (ADRD). The primary purpose of this research study is to determine the prevalence and severity of dysphagia, risk factors for dysphagia development, recovery patterns of dysphagia over time, and the impact of dysphagia on health outcomes, quality of life, and care partner burden in adult ICU survivors with PICS.
详细描述
This study will involve one in-person research visit for community dwelling adults and two research visits for critically ill adults (one in the ICU, one 3-months post-hospital discharge) that will last approximately 1 hour and will consist of a screening, cough testing, swallow function testing, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of ICU survivors will complete questionnaires at the 3-month follow up visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •community-dwelling adults:
- •adult ≥18 years old
- •no prior history of neurological diseases or respiratory diseases
- •no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region
- •no prior history of dysphagia.
排除标准
- •community-dwelling adults:
- •<18 years old
- •neurological disease or respiratory disease diagnosis
- •history of head and neck cancer/surgery to the head and neck region
- •history of dysphagia.
- •Inclusion criteria critically-ill adults:
- •adult ≥ 18 years old
- •ICU patients requiring monitoring or treatment for respiratory failure and/or shock (e.g., hypovolemic, septic, and/or cardiogenic)
- •cognitive capacity and willingness to provide informed consent
- •medically stable for testing (e.g., can sit upright, respiratory status is stable [Sp02 > 90%, off mechanical ventilation or CPAP/BiPAP for > 30 minutes, respiratory rate < 30 bpm], and Richmond Agitation-Sedation Scale score is 0 (awake and alert).
- •Exclusion criteria critically ill adults:
- •neurological disease diagnosis
- •history of head and neck cancer/surgery to the head and neck region
- •history of dysphagia prior to ICU admission.
- •Inclusion criteria caregivers:
- •caregiver of critically ill adult who meets inclusion criteria for study
- •willing to complete questionnaire.
- •Exclusion criteria caregivers:
- •not a caregiver of critically ill adult
- •unwilling to complete questionnaire.
研究组 & 干预措施
Healthy community dwelling adults
Healthy community dwelling adults who meet the inclusion criteria for the study will be enrolled.
ICU survivors and their care partners
Critically ill adults and their care partners who meet inclusion criteria for the study will be enrolled.
结局指标
主要结局
Swallowing safety and efficiency
时间窗: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
The validated Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale will be used to measure swallowing safety and efficiency.
次要结局
- Voluntary cough peak expiratory flow(During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.)
- Grip strength(During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.)
- Tongue strength(During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.)
- Swallowing and Eating Related Fatigue Questionnaire (SERF)(During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.)
- Eating Assessment Tool 10 (EAT-10)(During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.)
- 3 oz water swallow test(During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.)
- Reflex cough(During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.)
- Screening for Oral Frailty Tool (SOFT)(During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.)
- Swallowing Related Quality of Life Questionnaire (SWAL-QOL)(During baseline visit at time of enrollment for community dwelling adults. 3 months post-hospital discharge for critically ill adults.)
- Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire(3 months post-hospital discharge for care partners of critically ill adults.)
研究者
Cara Donohue, Ph.D. CCC-SLP
Assistant Professor, Director of Medical Speech-Language Pathology
Vanderbilt University Medical Center