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Status unknownNCT04977843Updated Jul 27, 2021

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.

An interventional study of EARLY BRONCHOALVEOLAR LAVAGE in Traumatic Brain Injury and Ventilator Associated Pneumonia, sponsored by Jinnah Hospital. Status unknown at 1 site in Pakistan. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-07-27.

Sponsored by Jinnah Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
15 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Traumatic Brain Injury
  • Ventilator Associated Pneumonia

Keywords

  • Early Bronchoalveolar Lavage
  • CPIS
03

In context

Brain Injuries, Traumatic

1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.

This study's planned enrollment of 60 is close to the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

Jinnah Hospital is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    E-BAL

    E-BAL carried out within 48 hours

    Procedure: EARLY BRONCHOALVEOLAR LAVAGE

  • No intervention
    Conservative/Control

    Standard of care management

Interventions

  • ProcedureEARLY BRONCHOALVEOLAR LAVAGE

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 days

  2. Ventilation Days

    Number of days patient remains on ventilator

    Time frame: up to three weeks

  3. ICU stay Total

    Number of days patient remains in ICU

    Time frame: up to four weeks

07

Study locations

1 of 1 sites recruiting
  • Jinnah Hospital
    Lahore, Punjab Province 54550, Pakistan
    • Nazir Ahmed, MBBS · Contact · 0092-3324583747
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Dec 2021, 6 months after the start.

Of 491 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's planned 6 months is below that.

Counting every sponsor, half of 515 studies reached it within 36 months; a quarter within 21 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2021
First posted
Jul 27, 2021
StartActual
Jun 1, 2021
Primary completionEst.
Dec 30, 2021
CompletionEst.
Dec 30, 2021
Last update
Jul 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04977843
Lead sponsor
Jinnah Hospital
Responsible party
Nazir Ahmed (medical officer trainee, Jinnah Hospital) — Principal investigator
First posted
Jul 27, 2021
Start date
Jun 1, 2021
Primary completion
Dec 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Jul 27, 2021

Study contacts

NAZIR AHMED, M.S
Contact
nangrejonazir@gmail.com
0092-3324583747
Syed S Hussain, MBBS, FCPS
study chair · Jinnah Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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