Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183749
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-12-12
Brief Title:
Predictors of Mortality in Traumatic Brain Injury Patients in Intensive Care Unit
Sponsor:
Umraniye Education and Research Hospital
Organization:
Umraniye Education and Research Hospital
Study Overview
Official Title:
Predictors of Mortality in Patients With Traumatic Brain Injury in the Tertiary Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary outcome of this study was to identify mortality predictorsrisk factors affecting mortality and secondary outcome was to determine the distribution of brain injury types and other parameters according to type of trauma in patients with TBI treated in anesthesia-reanimation tertiary ICU
Detailed Description:
Patients with traumatic brain injury TBI especially severe cases are referred to neurotrauma centers where they are managed in neurosurgery intensive care units ICU or anesthesia-reanimation intensive care units as in Turkey Such patients comprise a significant portion of patients managed in ICU with high rates of mortality and morbidity even with the best medical and neurosurgical care It is crucial to identify the factors that contribute to mortality for TBI as it has a high incidence rate with significant mortality and morbidityThe aim of this study was to identify mortality predictorsrisk factors affecting mortality and was to assess the distribution of brain injury in patients with TBI in anesthesia-reanimation ICU
After receiving approval from the institutional Ethics Committee we retrospectively identified patients over the age of 18 who were diagnosed with TBI by neurosurgery in the emergency department and were hospitalized in the 3rd stage Anesthesiology and Reanimation-ICU for more than 24 hours within the last two-years period using hospital computer records They were then included in our studyThe patients were evaluated in 2 groups according to etiology as head trauma accompanied by general body trauma Group 1 and isolated head trauma Group 2
Types of brain injuryhemorrhage due to head trauma were determined as intracerebral hemorrhage ICH subdural hematoma SDH epidural hematoma EDH traumatik subarachnoid hemorrhage tSAH cerebral contusion-diffuse axonal injury DAI and hemorrhages in which two or more of these conditions were combined MIX
Parameters included age sex GCS at admission APACHE II score estimated mortality actual mortality type of brain injury presence or absence of surgical intervention presence or absence of skull fracture length of ICU stay duration of intubation presence or absence of sedation presence or absence of tracheotomy and outcome of disease All data regarding above-mentioned parameters were extracted from patient files and electronic database
It was aimed to assess relationship between mortality and parameters such as age sex surgical intervention type of brain injury duration of intubation duration in ICU GCS score and APACHE II scores skull fracture in cases with TBI as primary outcome it was also aimed to determine the distribution of etiology and these parameters over the TBI patients as secondary outcome
As surgical intervention operations with indications of bleeding control andor control of intracranial pressure performed by neurosurgery department were taken into consideration for analysis
In all patients diagnosis was made based on CT scan andor MR imaging study obtained at arrival to emergency department as a part of emergency protocol
After receiving approval from the institutional Ethics Committee we retrospectively identified patients over the age of 18 who were diagnosed with TBI by neurosurgery in the emergency department and were hospitalized in the 3rd stage Anesthesiology and Reanimation-ICU for more than 24 hours within the last two-years period using hospital computer records They were then included in our studyThe patients were evaluated in 2 groups according to etiology as head trauma accompanied by general body trauma Group 1 and isolated head trauma Group 2
Types of brain injuryhemorrhage due to head trauma were determined as intracerebral hemorrhage ICH subdural hematoma SDH epidural hematoma EDH traumatik subarachnoid hemorrhage tSAH cerebral contusion-diffuse axonal injury DAI and hemorrhages in which two or more of these conditions were combined MIX
Parameters included age sex GCS at admission APACHE II score estimated mortality actual mortality type of brain injury presence or absence of surgical intervention presence or absence of skull fracture length of ICU stay duration of intubation presence or absence of sedation presence or absence of tracheotomy and outcome of disease All data regarding above-mentioned parameters were extracted from patient files and electronic database
It was aimed to assess relationship between mortality and parameters such as age sex surgical intervention type of brain injury duration of intubation duration in ICU GCS score and APACHE II scores skull fracture in cases with TBI as primary outcome it was also aimed to determine the distribution of etiology and these parameters over the TBI patients as secondary outcome
As surgical intervention operations with indications of bleeding control andor control of intracranial pressure performed by neurosurgery department were taken into consideration for analysis
In all patients diagnosis was made based on CT scan andor MR imaging study obtained at arrival to emergency department as a part of emergency protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None