Transcranial Doppler guided management of severe traumatic brain injury in trauma intensive care unit
- Conditions
- Concussion, (2) ICD-10 Condition: S061||Traumatic cerebral edema, (3) ICD-10 Condition: S062||Diffuse traumatic brain injury, (4) ICD-10 Condition: S063||Focal traumatic brain injury, (5) ICD-10 Condition: S064||Epidural hemorrhage, (6) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (7) ICD-10 Condition: S068||Other specified intracranial injuries, (8) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, (9) ICD-10 Condition: S069||Unspecified intracranial injury,
- Registration Number
- CTRI/2021/12/038456
- Lead Sponsor
- PGIMER
- Brief Summary
Traumatic brain injury (TBI) is the leading cause of morbidity, mortality and disability across the globe and contributes to almost 40% of all injury-related deaths.The disabilities associated with TBI significantly increase the disease as well as the socio-economic burden.Though studies in the past evaluating the diagnostic and/or prognostic role of TCD in TBI, however most of these studies were observational cohort studies. Data from randomized, controlled trials of TCD monitoring in the management of patients with severe TBI are lacking. We thus plan to conduct this study with the aim of determining whether the information derived from TCD-guided neuromonitoring of patients with severe TBI as an add on to the clinical and radiological examination will improve patient outcomes. Our hypothesis is that ICU management protocol based on the use of TCD monitoring would reduce the ICU stay, thus reducing morbidity and improve patient outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
- 1.Adult patients 18-65 years of age, with severe TBI (Glasgow Coma Scale 3-8) 25 at the time of admission to Intensive Care Unit 2.Admitted to Trauma Intensive Care Unit (ICU) for mechanical ventilatory support and conservative management.
- 3.Admitted to Trauma ICU within 48 hours of injury.
- 1.Pregnant females and pediatric patients 2.Relatives unwilling to give consent for participation in the study 3.Patients admitted to hospital >24 of injury 4.Glasgow Coma Scale (GCS) of 3 with bilateral fixed and dilated pupils 5.Non-survivable injury like decapitation or hemicorporectomy.
- •Inability to obtain ultrasound window for performing Transcranial doppler (TCD).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional status and orientation at 3 months following injury, assessed with the use of the Extended Glasgow Outcome Scale [GOS-E](annexure I) and the Disability Rating Scale [DRS](annexure II). 3 months post injury
- Secondary Outcome Measures
Name Time Method Frequency of neurosurgical procedures end of icu stay Time to hospital discharge end of hospital stay GCS at the end of hospital stay end of hospital stay Brain-specific treatments received end of icu stay Adverse events/complications, if any end of icu stay Total length of ICU stay end of icu stay Incidence of neurological worsening end of icu stay . Total ventilator days end of icu stay
Trial Locations
- Locations (1)
Department of Anesthesia and Intensive Care,POST GRADUATE INSTITUTE OF MEDICAL SCIENCES
🇮🇳Chandigarh, CHANDIGARH, India
Department of Anesthesia and Intensive Care,POST GRADUATE INSTITUTE OF MEDICAL SCIENCES🇮🇳Chandigarh, CHANDIGARH, IndiaBISMAN JEET KAUR KHURANAPrincipal investigator9811911223khurana.bisman@gmail.com