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临床试验/NCT06395740
NCT06395740已完成4 期

Comparison Between Incidence of Pneumonia in Non-ventilated Cerebrovascular Stroke Patients Suffering From Bulbar Palsy Depending on Nasogastric Tube Feeding and Those Who Are Totally Parenterally Fed.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月5日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Incidence of pneumonia

研究概览

简要总结

One of the most serious complications in the critically ill patient complaining of bulbar palsy is aspiration pneumonia. These patients are scheduled for nasogastric tube feeding trying to avoid recurrent aspiration and subsequent aspiration pneumonia. Even though, the risk of aspiration is still present. Putting a total parenteral nutrition regimen for these patients is a supposed strategy to avoid aspiration pneumonia till recovery from bulbar palsy or planning for tracheostomy and or feeding gastrostomy.

详细描述

Aspiration pneumonia in cerebrovascular patients suffering from bulbar palsy can reach up to 60 %. (Martino R et al., 2012). All swallowing stages can be affected in cerebrovascular stroke patients. Difficulty in deglutition lower oesophageal sphincter dysfunction, delayed gastric empty and subsequent increase in gastric residual volume and decreased lower oesophageal sphincter tone and subsequent increase in gastroesophageal reflux all can be found in patients suffering from cerebrovascular stroke. (Schaller BJ et al., 2006).

As enteral feeding via oral route is risky in patients suffering from bulbar palsy, nasogastric tube is being used as a mode of enteral feeding till recovery from bulbar palsy or doing a gastrostomy tube as an alternative mode for enteral feeding. There is no survival benefit for early enteral feeding via nasogastric tube when compared with delayed tube feeding as formulated by the Feed or Ordinary Diet (FOOD) trial and suggested delaying nasogastric feeding may decrease mortality in bulbar palsy patients (Dennis MS et al., 2005).

Although this is the common practice to get the nutritional needs, there is evidence that early enteral feeding is not nutritionally superior to early TPN administration. Moreover, there is more rapid recovery of both albumin and protein in patients started TPN rather than those of enteral feeding at least for the first 2 weeks of stroke which is the time of maximum risk of malnutrition (Yamada SM, 2015).

Bulbar palsy non ventilated cerebrovascular patients who are scheduled for nasogastric tube feeding are at a high risk of aspiration pneumonia, with incidence from 33% to 70% (Langdon PC et al., 2009). Dysfunction of Lower oesophageal sphincter is exaggerated by nasogastric tube, that means increase of incidence of gastroesophageal reflux and micro aspiration (Gomes GF., 2003). Also, nasogastric tube can be colonized by gram negative bacteria as nasogastric tube change gastric acidity and promote bacterial colonization and increasing risk of micro aspiration and sequent aspiration pneumonia (Spilker CA et al., 1996). So non ventilated cerebrovascular stroke patients suffering from bulbar palsy and scheduled for nasogastric tube enteral feeding are at risk of aspiration pneumonia (Warusevitane A et al., 2014).

Even though parenteral feeding has the advantage of protection from aspiration pneumonia, it has risk of complications like hyperglycaemia, refeeding-syndrome, bone demineralisation, catheter infections), fortunately these complications can be minimised by carefully monitoring patients and the use of teams for nutrition support especially during long-term PN.( Hartl WH et al., 2009)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • •1. cerebrovascular stroke patients either ischemic or haemorrhagic within first 7 days
  • •Age above 18 years
  • •patients suffering from bulbar palsy.

排除标准

  • •- Mechanically ventilated patients at first presentation.
  • •Patients suffering from attacks of fits.
  • •Patients suffering from signs and symptoms of pneumonia before attack of cerebrovascular stroke.
  • •4. Patients suffering from degenerative neurological diseases.
  • •Patients with developmental delay or neurological disease.
  • •Patients with hepatic or renal coma.
  • •Patients with hemodynamic instability.

研究组 & 干预措施

enteral nutrition group

Experimental

patients will be scheduled for enteral nutrition via nasogastric tube.The amount of nasogastric feed given each day will be calculated according to the patient's calorie requirement and administered as 100 ml nasogastric tube feeding every four hours escalating to 200 ml every four hours according to patients' toleration and caloric needs. Patients will be positioned at ≥ 45° head-end elevation during feeds. They will be observed regularly during feeds, and the position of the nasogastric tube will be confirmed before each feed by auscultation by stethoscope.

干预措施: Enteral nutrtion (Other)

total parentral nutrition group

Experimental

patients will be scheduled for continuation of NPO strategy except for medications to be given via nasogastric tube till 14 days from day of stroke with fulfilment of nutrition requirement by parenteral route

干预措施: TPN (Other)

结局指标

主要结局

Incidence of pneumonia

时间窗: within 14 days from inclusion in study

guided by The British Thoracic Society recommendations for definition pneumonia

次要结局

  • catheter related infection(14 days from inclusion in study)
  • mechanical ventilation(30 days from inclusion in the study,)
  • mortality rate(30 days from inclusion in the study,)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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