DYsphAgia In Mechanically Ventilated ICU patientS (DYnAMICS) - a Prospective Multicentre Observational Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Number of patients with dysphagia at discharge from ICU
研究概览
简要总结
Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. In the present observational analysis, the investigators aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of ICU patients post invasive mechanical ventilation.
详细描述
Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. In the present observational analysis, we aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of ICU patients post invasive mechanical ventilation.
ICU patients are at increased risk for oropharyngeal dysphagia following endotracheal intubation. However, the incidence, respective underlying causes and clinical consequences of dysphagia in ICU patients are currently understudied. The impact on clinical outcomes of respective ICU patients thus remains currently unclear. A systematic review [1] reported highly variable dysphagia frequency rates depending on the time of mechanical ventilation/ intubation.
However, previous clinical trials were heterogeneous in design, methods of screening, and study outcome. The overall quality of evidence is considered low. The systematic review highlights the limited available evidence for dysphagia following intubation and hence the need for high-quality prospective trials. A recent retrospective single-centre trial [2] in a tertiary care ICU demonstrated a high presence of dysphagia in mechanical ventilated (MV) patients following extubation. Screening was performed using bedside swallowing evaluation (BSE).
In a prospective observational analysis, we aim to further elucidate the impact of dysphagia on respective clinical outcomes in ICU patients after mechanical ventilation.
研究设计
- 研究类型
- Observational
- 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
- •all adult ICU patients post mechanical ventilation (observational analysis)
排除标准
- •patients prone to die / moribund patients/ or dying patients
- •patients post oesophageal resection / with oesophageal rupture
结局指标
主要结局
Number of patients with dysphagia at discharge from ICU
时间窗: expected average time frame about 72hrs. (at end of ICU stay/ discharge)
次要结局
- Number of patients re-intubated, reason for re-intubation, and antibiotic use(during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period))
- Number of patients with dysphagia and (association to) sedatives prescribed(during ICU stay (expected average length of ICU stay is about 72 hrs.))
- Number of patients with dysphagia according to disease severity and routine laboratory indices(during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period))
- Duration of dysphagia/ course of dysphagia severity during ICU/ hospital stay(during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period, expected average length of hospital stay is about 14 days))
- Number of patients with dysphagia in predefined patient categories: ICU-acquired weakness, stroke/ cerebrovascular infarction, traumatic brain injury, movement disorders, sepsis, cardiogenic, post abdominal surgery, trauma(during ICU stay (expected average length of ICU stay is about 72 hrs.))
- Other clinical/ epidemiological factors associated with dysphagia (incl. descriptive analyses)(during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period))
- Number of patients with dysphagia and association to duration of mechanical ventilation(during ICU stay (expected average length of ICU stay is about 72 hrs.))
- Number of patients with dysphagia and dysphagia severity at first assessment(expected average time frame about 48 hrs.)
- Number of patients with dysphagia / incl. dysphagia severity at discharge(expected average time frame about 72 hrs. (end of ICU stay))
- Number of patients with dysphagia (in association) to tube size, body weight/ BMI etc.(during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period))
- Number of chest X-ray examinations performed among patients w/ and w/o dysphagia(during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period, expected average length of hospital stay is about 14 days))
- Association of dysphagia and related ICU- and intrahospital mortality/ readmission rate(during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period))
- Association of dysphagia and related ICU length of stay/ hospital length of stay(during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period))
研究者
Jörg Schefold
Principal Investigator/ Coordinating Investigator
Insel Gruppe AG, University Hospital Bern