Effect of E-BAL on Severity of VAP Assessed Through CPIS on the Patients of Traumatic Brain Injury in Neurocritical Care, Also Effect on Days of Ventilation and ICU Stay.

NCT04977843 | Unknown DMC

• 1 other identifier: 62/erb
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Severe traumatic brain injury (STBI) is a leading cause of disability, mortality, and economic burden worldwide. The impact of severe traumatic brain injury (STBI) on the economy of developing countries like Pakistan is distressing. Pakistan has a large proportion of the young adult population in the World. Motorbike is the most common locomotive vehicle. These young ones are in the economically productive part of their lives. Their loss is an economical set back not only for their families but also for the Nation. Patients with STBI need standardized management in Neuro-critical care unit (NCCU). Although the setup and maintenance cost of an effective NCCU is one of the major burden on the budget of any public sector hospital, but the young survivor in turn can be productive for the Nation. During mechanical ventilation, severe traumatic brain injury patients frequently develop ventilator-associated pneumonia (VAP). Ventilator-associated pneumonia can be evaluated using Clinical pulmonary infection score (CPIS). CPIS is considered as an important clinical indicator of pneumonia in NCCU. Bronchoalveolar Lavage (BAL) is a minimally invasive procedure done with instillation of normal saline into subsegments of the lung followed by suction and collection of the instilled fluid for analysis with flexible bronchoscope. Patients with moderate and severe traumatic brain injury usually present with altered conscious level, and most of them already have aspiration of vomitus, debris and secretions which increase the risk of VAP in them. Bronchoalveolar lavage can be helpful in preventing this dreadful VAP by clearing the airways. The aim of this study is to find out the effect of early Bronchoalveolar Lavage on severity of development of VAP assessed through clinical pulmonary infection score (CPIS) in TBI patients.

Conditions

Traumatic Brain Injury; Ventilator Associated Pneumonia

Keywords

Early Bronchoalveolar Lavage; CPIS

Outcome Measures

Primary Outcomes (3)

• VAP severity

  The study will help to figure out the effect of early bronchoalveolar lavage on decreasing the severity of VAP which will be assessed through CPIS

  10 days

• Ventilation Days

  Number of days patient remains on ventilator

  up to three weeks

• ICU stay Total

  Number of days patient remains in ICU

  up to four weeks

Study Arms (2)

E-BAL

EXPERIMENTAL

E-BAL carried out within 48 hours

Procedure: EARLY BRONCHOALVEOLAR LAVAGE

Conservative/Control

NO INTERVENTION

Standard of care management

Interventions

EARLY BRONCHOALVEOLAR LAVAGE PROCEDURE

E-BAL done with instillation of 100cc normal saline and sucked out

E-BAL

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between the age of 15-60 years with traumatic brain injury,
• Presenting GCS between 5 to 10,
• On mechanical ventilation,
• Either gender.

You may not qualify if:

• Patient undergoing neurosurgical procedure.
• Poly trauma.
• An underlying malignancy.
• Patients admitted with any medical comorbidity including known case of restrictive or infiltrative lung disease, chronic liver disease, and chronic kidney failure.
• Patients who expired within 10 days of admission.

Sponsors & Collaborators

• Jinnah Hospital: lead

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 54550, Pakistan

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Syed S Hussain, MBBS, FCPS

  Jinnah Hospital Lahore

  STUDY CHAIR

Central Study Contacts

NAZIR AHMED, M.S

CONTACT

0092-3324583747; nangrejonazir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical officer trainee

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 27, 2021
• Study Start: June 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

PA (1)