Development of Dysphagia Management Protocol for Adult Patients in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improved Swallow Capacity
研究概览
简要总结
Dysphagia (swallowing disorders) in intensive care unit (ICU) patients is associated with poor outcomes, including aspiration pneumonia, prolonged hospitalization, and increased mortality. Traditional dysphagia management approaches may be insufficient for the unique needs of critically ill patients. This study aims to evaluate the effectiveness of a newly developed ICU-specific dysphagia protocol compared to traditional therapy approaches.
详细描述
The aim of this study are:
- To compare the efficacy of traditional dysphagia therapy versus a developed ICU-specific protocol in improving swallowing function
- To assess the impact of both approaches on clinical outcomes including aspiration rates, time to oral intake, ICU length of stay, and pneumonia incidence
- To identify patient subgroups that may benefit most from the specialized protocol Methods Study Design
- Prospective randomized controlled trial
- Single-center study in a tertiary hospital ICU
- 1:1 randomization to intervention or control group Participants
- Total sample size: 90 adult ICU patients (45 per group)
- Inclusion criteria: Adult patients (≥18 years) admitted to ICU with confirmed dysphagia by bedside evaluation within 72 hours of admission
- Exclusion criteria: Preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected ICU stay <48 hours This study will provide evidence for the efficacy of a specialized dysphagia management protocol tailored to the unique needs of critically ill patients. If proven effective, the protocol could establish new standards of care for dysphagia management in ICU settings, potentially improving patient outcomes and reducing healthcare costs associated with dysphagia-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult patients (≥18 years) admitted to ICU with confirmed dysphagia by bedside evaluation within 72 hours of admission
- •GCS more then 8
排除标准
- •Preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected ICU stay <48 hours
研究组 & 干预措施
Comparison group
This Group will receive traditional dysphagia therapy.
干预措施: dysphagia therapy (Other)
Experimental Group
This group will receive treatment as per recently designed dysphagia management protocol, that includes the role of early mobilization, dietary intervention with varying postures, and overall care designed for first 48 hours.
干预措施: Designed protocol for dysphagia (Behavioral)
结局指标
主要结局
Improved Swallow Capacity
时间窗: 6 months
• Change in Functional Oral Intake Scale (FOIS) score from baseline to discharge (at discharge it should be more then 5 on its rating scale)
次要结局
- Improved Quality of Life(4 months)