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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.

Primary Purpose

Traumatic Brain Injury, Ventilator Associated Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
EARLY BRONCHOALVEOLAR LAVAGE
Sponsored by
Jinnah Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Traumatic Brain Injury focused on measuring Early Bronchoalveolar Lavage, CPIS

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Jinnah HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

E-BAL

Conservative/Control

Arm Description

E-BAL carried out within 48 hours

Standard of care management

Outcomes

Primary Outcome Measures

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
Ventilation Days
Number of days patient remains on ventilator
ICU stay Total
Number of days patient remains in ICU

Secondary Outcome Measures

Full Information

First Posted
June 9, 2021
Last Updated
July 24, 2021
Sponsor
Jinnah Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04977843
Brief Title
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.
Official Title
Effect of Early Bronchoalveolar Lavage on Severity of Ventilator Associated Pneumonia Assessed Through Clinical Pulmonary Infection Score on the Patients of Traumatic Brain Injury in Neurocritical Care.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Severe traumatic brain injury is a serious and ever growing issue of public health and the social economy of the World. It comprises 10% of all brain injuries and contributes to the high proportion of disabilities and deaths (McGarry et al., 2002; Mosenthal et al., 2002). STBI has a high mortality rate with prolonged hospital stay on average 17.5 days (Tagliaferri et al., 2006). The 14-day mortality on average remained 30.2%and most patients died in 48 hours (Braun CT, 2015). In the United States, approximately 235,000 patients were treated in the hospital per year due to traumatic brain injury (TBI). The estimated annual death rate in the US is about 50,000 cases per annum, with 21 to 400 billion US dollar annual costs due to TBI(Corrigan, Selassie and Orman, 2010; Marin, Weaver and Mannix, 2017). The annual cost of hospitalization due to traumatic brain injury (TBI) in China was 800 billion US dollars, with a mortality rate 9.8% (Liet al., 2015). The complete recovery of a patient of STBI to pre-injury level is uncommon. Approximately 60% of the patient has ongoing impairment in the area of cognitive competency, gross motor activity, and recreational activity (Dikmen et al., 2003). Patients with STBI can have airway obstruction, aspiration, and hypoxia (Jovanovic et al., 2015). Mechanical ventilation is indicated in many patients with severe TBI(Jovanovic et al., 2015; Li et al., 2015). It maintains the oxygenation, protects airways, and maintains respiration. Most of the patients about 80% wean of early within 7 days from the mechanical ventilation without a respiratory problem, once the acute physiological disorder is corrected. However, 20% of patients still require prolonged mechanical ventilation after 7 days (Hess and MacIntyre, 2011). During the first four days, ventilator-associated pneumonia occurs in about 60% of the patients with severe traumatic brain injury (Ensault et al., 2017). The early systemic inflammatory response to head trauma patients predispose to early-onset VAP (Hedrick TL et al., 2008), while late-onset VAP that occurs after five days of mechanical ventilation (MV) is caused mainly by drug-resistant bacteria (Garnacho-Montero et al., 2014). Patients on mechanical ventilation have high morbidity, mortality, and infection rate due to acute respiratory distress syndrome and pulmonary embolism from venous thromboembolism (Nair and Niederman, 2015). They also have decreased consciousness levels, disrupted natural defense barriers, decreased mobility, and lack of ability to protect the airways which can lead to pulmonary complications. Data is limited about effect of VAP in patients with STBI outcome. However multi organ failure has been identified as an independent contributor of poor outcomes in patients with severe TBI(Zygun et al., 2005). A simple tool for the diagnosis of VAP was needed, thus a scoring system was developed in 1991, which included 7 clinical parameters for VAP diagnosis and it was named as Clinical Pulmonary Infection Score (CPIS) (Pugin J. Et al 1991) . The diagnosis of VAP was made using body temperature, leukocyte count and morphology, the character of tracheal secretion, PaO2 / FiO2 ratio, presence of pulmonary infiltration and its progression and microbiological culture results. A score of 6 or more suggests VAP (Basyigit. 2017). 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. Loftus et al concluded in their study in 2017 that over half of all intubated patients with head or chest injury had evidence of pneumonia on Early Bronchoalveolar Lavage (E-BAL) performed within 48 hours of admission. E-BAL was associated with early discontinuation of antibiotics (7.3 vs 9.2 days), fewer days on mechanical ventilation (10.5 vs 16), fewer tracheostomies (49% vs 75%) and shorter ICU length of stay compared to L-BAL triggered by clinical suspicion of pneumonia (12 vs 17days). So, they found E-BAL useful for intubated patients with TBI or chest trauma. But the effect of this early lavage on severity of VAP assessed on CPIS is lacking. This study will help in determining the effect of early bronchoalveolar lavage on VAP in ventilated moderate and severe traumatic brain injury patients and will reflect the effect of early bronchoalveolar lavage on VAP through CPIS which can serve as prognostic indicator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Ventilator Associated Pneumonia
Keywords
Early Bronchoalveolar Lavage, CPIS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-BAL
Arm Type
Experimental
Arm Description
E-BAL carried out within 48 hours
Arm Title
Conservative/Control
Arm Type
No Intervention
Arm Description
Standard of care management
Intervention Type
Procedure
Intervention Name(s)
EARLY BRONCHOALVEOLAR LAVAGE
Intervention Description
E-BAL done with instillation of 100cc normal saline and sucked out
Primary Outcome Measure Information:
Title
VAP severity
Description
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
Time Frame
10 days
Title
Ventilation Days
Description
Number of days patient remains on ventilator
Time Frame
up to three weeks
Title
ICU stay Total
Description
Number of days patient remains in ICU
Time Frame
up to four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the age of 15-60 years with traumatic brain injury, Presenting GCS between 5 to 10, On mechanical ventilation, Either gender. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NAZIR AHMED, M.S
Phone
0092-3324583747
Email
nangrejonazir@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed S Hussain, MBBS, FCPS
Organizational Affiliation
Jinnah Hospital Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
Jinnah Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54550
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazir Ahmed, MBBS
Phone
0092-3324583747

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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.

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