Traumatic Brain InjuryNCT04977843
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.
A study testing EARLY BRONCHOALVEOLAR LAVAGE in people with Traumatic Brain Injury and Ventilator Associated Pneumonia, run by Jinnah Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Traumatic Brain Injury, Ventilator Associated Pneumonia
- What is being tested?
- EARLY BRONCHOALVEOLAR LAVAGE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the age of 15-60 years with traumatic brain injury,
- Presenting GCS between 5 to 10,
- On mechanical ventilation,
- Either gender.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Hospital
Lahore, Punjab Province, 54550
Nazir Ahmed, MBBS, 0092-3324583747
About this study
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.
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.
Read more
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.
- Being tested
- EARLY BRONCHOALVEOLAR LAVAGE
- Keywords
- Early Bronchoalveolar Lavage, CPIS
- Medical subject headings
- Brain Injuries, Traumatic, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EARLY BRONCHOALVEOLAR LAVAGEProcedure or surgery
E-BAL done with instillation of 100cc normal saline and sucked out
| Study group | Role | What they receive |
|---|---|---|
| E-BAL | Experimental | E-BAL carried out within 48 hours Receives: Procedure: EARLY BRONCHOALVEOLAR LAVAGE |
| Conservative/Control | No intervention | Standard of care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Ventilation Days
Number of days patient remains on ventilator
Measured: up to three weeks
ICU stay Total
Number of days patient remains in ICU
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Jun 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazir Ahmed, Jinnah Hospital
- Investigators
- Syed S Hussain, MBBS, FCPS, Study chair, Jinnah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977843
- Sponsor's protocol ID
- 62/erb
- Status last verified
- Jul 2021
- First submitted
- 9 Jun 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04977843
- Acronym / sponsor ID
- 62/erb
- Keywords
- Early Bronchoalveolar Lavage, CPIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jinnah HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-BAL | Experimental | Procedure: EARLY BRONCHOALVEOLAR LAVAGEE-BAL carried out within 48 hours |
| Conservative/Control | No intervention | –Standard of care management |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients between the age of 15-60 years with traumatic brain injury,
- Presenting GCS between 5 to 10,
- On mechanical ventilation,
- Either gender.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EARLY BRONCHOALVEOLAR LAVAGEE-BAL done with instillation of 100cc normal saline and sucked out | Procedure or surgery | E-BAL |
Primary outcome
VAP severity
Time frame: 10 days
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
Time frame: up to three weeks
Number of days patient remains on ventilator
ICU stay Total
Time frame: up to four weeks
Number of days patient remains in ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed S Hussain, MBBS, FCPS study chair
Jinnah Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EARLY BRONCHOALVEOLAR LAVAGE in people with Traumatic Brain Injury and Ventilator Associated Pneumonia, run by Jinnah Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NAZIR AHMED, M.S (0092-3324583747, nangrejonazir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAP severity (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.