Aspiration Pneumonia in Cerebrovascular Stroke Patients Suffering from Bulbar Palsy (TPN)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Aspiration Pneumonia
• Intervention / Treatment: Other: Enteral nutrtion; Other: TPN

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Abdallah soudi; Phone Number: 02 01111228925; Email: dr.soudi2014@med.asu.edu.eg
• Study Contact Backup: Name: Foad Farouk; Phone Number: 02 01095022127

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Recruiting
    • Abdallah Mahmoud Zaki Soudi
    • Contact: Abdallah soudi; Phone Number: 02 01111228925; Email: dr.soudi2014@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. cerebrovascular stroke patients either ischemic or haemorrhagic within first 7 days 2. Age above 18 years 3. patients suffering from bulbar palsy.

Exclusion Criteria:

- Mechanically ventilated patients at first presentation. 2. Patients suffering from attacks of fits. 3. Patients suffering from signs and symptoms of pneumonia before attack of cerebrovascular stroke.

4. Patients suffering from degenerative neurological diseases. 5. Patients with developmental delay or neurological disease. 6. Patients with hepatic or renal coma. 7. Patients with hemodynamic instability.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enteral nutrition group; 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.	Other: Enteral nutrtion; enteral nutrition via nasogastric tube.
Experimental: total parentral nutrition group; 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	Other: TPN; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pneumonia	guided by The British Thoracic Society recommendations for definition pneumonia	within 14 days from inclusion in study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mechanical ventilation	Incidence of mechanical ventilation in both groups	30 days from inclusion in the study,
mortality rate	incidence of mortality in both groups	30 days from inclusion in the study,
catheter related infection	incidence of catheter related infection	14 days from inclusion in study

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Adel ELansary, Faculty of Medicine, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Neurodegenerative Diseases; Motor Neuron Disease; Stroke; Pneumonia; Pneumonia, Aspiration; Bulbar Palsy, Progressive
• Other Study ID Numbers: FMASU R65/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No