The Relationship Between Oral and Suprahyoid Muscle Wasting and Dysphagia in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Measure the extent and rate of muscle wasting
研究概览
简要总结
The goal of this study is to find out how muscle wasting in the mouth and throat affects swallowing (dysphagia) in adults who are critically ill and being treated in intensive care units.
The main aims of this research study are to understand: how much and how quickly the oral and suprahyoid muscles waste in critically ill participants, and whether muscle wasting causes problems with swallowing. The investigators will compare critically ill participants with non-critically ill participants to determine if muscle wasting is linked to swallowing problems.
In this study, participants will have the size and strength of their mouth and throat muscles measured at four different times during their critical care admission and hospital stay. Tests will also be performed to check how well and how safely participants can swallow. Tongue strength will be measured, and participants will answer questions about their experience with swallowing and eating using patient-reported outcome measures.
This study may help identify better ways to diagnose and treat swallowing problems in people who are critically ill, to support safe eating and drinking and promote faster recovery.
详细描述
Background:
Dysphagia is a common and serious complication among critically ill patients admitted to intensive care units (ICUs). Up to 62% of patients who require mechanical ventilation experience dysphagia, which can lead to aspiration pneumonia, malnutrition, longer hospital stays, and increased mortality. Muscle wasting is a known consequence of critical illness and is associated with poor functional outcomes. The contribution of oral and suprahyoid muscle wasting to dysphagia in critically ill participants is poorly understood. This study aims to prospectively evaluate muscle wasting and its impact on swallowing function in critically ill adults.
Ethical Approval:
This study has Research Ethics Committee and Health Research Authority approval.
Study Objectives:
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
- 否
入选标准
- •Adults >18 years
- •Receiving mechanical ventilation via endotracheal tube and/or tracheostomy. Expected to receive ventilation for at least 72 hours.
- •Expected to survive admission and spend more than 7 days in the intensive care unit.
- •Control participants
- •Adults >18 years
- •Receiving ward-based care.
- •Expected to survive hospital admission. Present with a primary medical diagnosis of acute medical or surgical illness, not requiring critical care admission.
排除标准
- •Applies to both critically ill and control participants.
- •Pregnancy
- •Patients with a diagnosis of a primary neuromuscular pathology (e.g., motor neurone disease), central nervous system disease (e.g., stroke, Guillain barre), traumatic brain injury, connective tissue disease (e.g., scleroderma), head and neck cancer, previous surgery or radiotherapy to the head and neck.
结局指标
主要结局
Measure the extent and rate of muscle wasting
时间窗: Day 1, 3, 7 and 10 of intensive care unit admission
To measure the extent and rate of change in cross-sectional area of the oral and suprahyoid muscles in critically ill adults using bedside ultrasound across four time points. The extent and rate of muscle wasting will be assessed by measuring the change in cross-sectional area (mm²) of the oral and suprahyoid muscles using bedside ultrasound.
Relate muscle wasting to swallow physiology and safety
时间窗: Following day 10 ultrasound or when the patient is extubated and clinically appropriate for swallow assessment
To correlate changes in cross-sectional area to swallow physiology and safety in critically ill patients, using instrumental swallowing evaluations and tongue strength. To quantify the change in size of the oral and suprahyoid muscles, the cross-sectional area (mm²) will be measured using bedside ultrasound. Swallowing physiology and safety will be assessed using instrumental swallowing evaluations (e.g., Fiberoptic Endoscopic Evaluation of Swallowing (FEES)).The correlation coefficient (e.g., Pearson's or Spearman's r) between ultrasound-measured muscle cross-sectional area and instrumental swallowing assessment scores (e.g., the Penetration Aspiration Scale) will be used.
次要结局
- Measure electrophysiological features of swallow muscle activity(Day 1, 3, 7 and 10 of intensive care unit admission)
- Compare relationship between muscle mass and swallow physiology(Day 1, 3, 7 and 10 ultrasound assessments, swallow evaluation completed following day 10 ultrasound or when patient is extubated and clinically appropriate)
- Patient reported outcomes: Sydney Swallow Questionnaire(Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month)
- Patient reported outcomes: Swallowing Quality of Life (SWAL-QoL) Score(Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month)
- Patient reported outcomes: Functional Oral Intake Scale(Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month)
- Patient reported outcomes: Eating Assessment Tool-10 (EAT-10)(Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month)
- Compare the extent of muscle wasting in critically ill versus non-critically ill patient(Day 1, 3, 7 and 10 ultrasound evaluation vs single timepoint in non-critically ill patients)