Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified
Conditions
Interventions
Intervention1: SYNBIOTICS + Standard Care: Synbiotic therapy (Lactobacillus, Bifidobacterium, and the prebiotic fructooligosaccharide) administered twice daily enterally via nasogastric tube for 28 d
Sponsors
Dr Praveen Punniyamurthy
Eligibility
Inclusion criteria
Inclusion criteria: Patients receiving enteral nutrition via a nasogastric tube. Patients hospitalized with conditions such as trauma, stroke, sepsis, or other indications necessitating mechanical ventilation. Patients who either did not receive antibiotics or received prophylactic antibiotics for less than 48 hours prior to intubation
Exclusion criteria
Exclusion criteria: Patients with known immunosuppressive conditions (e.g., HIV/AIDS, malignancy, post-transplant status). Patients currently receiving, or having received within the past 3 months, corticosteroids, immunosuppressive agents, or chemotherapy. History of bowel surgery. Presence of malabsorption syndromes or short bowel syndrome History of synbiotic use within the past 1 month. Patients receiving end-stage or palliative care Known allergy or hypersensitivity to synbiotic components. Any contraindications to enteral (nasogastric) administration. Legally authorized representatives unwilling or unable to provide written informed consent. Patients who received antibiotics for more than 48 hours prior to intubation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Ventilator-Associated Pneumonia (VAP) (diagnosed using Modified Clinical Pulmonary Infection Score) Incidence of enteritis Timepoint: The study intervention will continue until extubation or a maximum of 28 days. Patients will be assessed daily while in the ICU and outcomes captured until ICU discharge or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation (in days) Length of ICU stay (in days) All cause ICU mortality Changes in Glasgow Coma Scale (GCS) scores Body temperature trends as a clinical marker of infection Changes in oxygenation status assessed by PaO2 & FiO2 ratio In cases of suspected infection, relevant investigations such as laboratory tests, chest X-rays, & computed tomography (CT) scans will be performed as clinically indicated Timepoint: The study intervention will continue until extubation or a maximum of 28 days. Patients will be assessed daily while in the ICU & outcomes captured until ICU discharge or death | — |
Countries
India
Contacts
Public ContactDr Praveen Punniyamurthy
SRM medical college hospital research institute, Kattankulathur, Chengalpattu
Outcome results
None listed