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Clinical Trial Summary

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.


Clinical Trial Description

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) Our goal in this study is to compare the incidence of aspiration pneumonia when keeping patients on total parenteral feeding regimen in comparison with early start of enteral feeding with nasogastric tube during early stage of stroke in stroke patients suffering from bulbar palsy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06395740
Study type Interventional
Source Ain Shams University
Contact Abdallah soudi
Phone 01111228925
Email dr.soudi2014@med.asu.edu.eg
Status Recruiting
Phase Phase 4
Start date May 5, 2024
Completion date December 31, 2024

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