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Transcranial Doppler guided management of severe traumatic brain injury in trauma intensive care unit

Completed
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
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
NameTimeMethod
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
NameTimeMethod
Frequency of neurosurgical proceduresend of icu stay
Time to hospital dischargeend of hospital stay
GCS at the end of hospital stayend of hospital stay
Brain-specific treatments receivedend of icu stay
Adverse events/complications, if anyend of icu stay
Total length of ICU stayend of icu stay
Incidence of neurological worseningend of icu stay
. Total ventilator daysend 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, India
BISMAN JEET KAUR KHURANA
Principal investigator
9811911223
khurana.bisman@gmail.com

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