Aspiration Pneumonia in Cerebrovascular Stroke Patients Suffering from Bulbar Palsy

NCT06395740 | Recruiting Phase 4 DMC

• 1 other identifier: FMASU R65/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspiration Pneumonia

Outcome Measures

Primary Outcomes (1)

• Incidence of pneumonia

  guided by The British Thoracic Society recommendations for definition pneumonia

  within 14 days from inclusion in study

Secondary Outcomes (3)

• mechanical ventilation

  30 days from inclusion in the study,

• mortality rate

  30 days from inclusion in the study,

• catheter related infection

  14 days from inclusion in study

Study Arms (2)

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.

Other: Enteral nutrtion

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

Other: TPN

Interventions

Enteral nutrtion OTHER

enteral nutrition via nasogastric tube.

enteral nutrition group

TPN OTHER

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

total parentral nutrition group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.
• \. 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Abdallah Mahmoud Zaki Soudi

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Adel ELansary

  Faculty of medicine, Ain Shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdallah soudi

CONTACT

01111228925; dr.soudi2014@med.asu.edu.eg

Foad Farouk

CONTACT

01095022127

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants are to be resuscitated at first and second days of admission keeping all of them NPO then to be randomly divided according to the method of obtaining their nutritional needs into two groups. Energy target will be set at 30 kcal/ kg IBW in males and 25 Kcal/kg IBW in females, while protein requirements will be set at 1.2 g/kg IBW First group (group A): Group A 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 guided by Aspen2020 guidelines. Second group (group B): Group B patients will be scheduled for enteral nutrition via nasogastric tube.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 5, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication

Locations

EG (1)