Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395740
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-29
Brief Title:
Aspiration Pneumonia in Cerebrovascular Stroke Patients Suffering From Bulbar Palsy
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPN
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None