Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Time to feeding resumption post extubation
研究概览
简要总结
Post-extubation dysphagia (PED) is a frequent but still underestimated condition in the intensive care units (ICU). In the international literature, the manifestations and consequences of PED lead to intra- and post-intensive care comorbidities.
The exact etiology of PED is unknown, but considered multifactorial. Numerous causes, acquired during ICU, can lead to a delay in the reintroduction of intravenous nutrition, or even favor the development of inhalation pneumopathy. One of these causes is the presence of the nasogastric tube.
The incidence of ECD varies from 3 to 62%. Its presence impacts morbidity and mortality. Preventive strategies for PED have only been studied with questionable methodologies.
The goal of ICU therapists is to detect PED as early as possible in order to implement curative strategies such as adapted nutrition and early swallowing rehabilitation.
详细描述
There are several tools available to diagnose PED. These assessment methods are numerous and not subject to consensus.
There are expensive instrumental methods requiring experts, which allow for accurate diagnosis but cannot be routinely used at the ICU patient's bed. For the ICU patient, bed-side clinical assessments seem more appropriate.
The "Yale swallow protocol" (YSP), is the most used test in the literature. Its sensitivity in predicting PED at 96.5%, a negative predictive value of 97.9% and a false negative rate of less than 2%, seem to make it the most suitable.
Currently, no recommendations have been made by French or international ICU societies on the appropriate time or method for PED assessment.
Regarding the treatment of PED, the literature shows that physiotherapy management would not significantly reduce its incidence, nor accelerate the resumption of per os feeding.
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
- None
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
- •Extubation prescribed by the attending physisian
- •Intubation for more than 48 hours
- •Presence of a nasogastric tube
- •RASS score equal to 0 at the time of screening.
排除标准
- •Gastric tube for gastric emptying (suction or bag)
- •Inability to remain alert for prolonged periods of time for the swallow test
- •Pre-existing dysphagia
- •Patient fed by nasogastric tube or jejunostomy before ICU stay
- •Tracheostomized patient
- •Contraindication to a bed head elevation > 30°.
- •Contraindication to the resumption of feeding
- •Pregnant or breastfeeding woman
- •Decision to limit active therapies
- •Protected person (under guardianship or curatorship) / Person under court protection
- •Person not affiliated to a social security system
结局指标
主要结局
Time to feeding resumption post extubation
时间窗: Day 1
If the patient passes the YSP or the classic swallowing test, a per-os diet resumption will be started and we will record the time of passing the test as the time of per-os feeding resumption.
次要结局
- ICU lenght of stay(Day 28)
- Rate of acquired pneumonia in the intensive care unit(Day 28)
- Weight loss during ICU stay(Day 28)
- Reintubation rate(Day 7)
- Undernutrition status(Day 7)