Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06183749 |
| Other study ID # |
trauma |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2024 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Umraniye Education and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary outcome of this study was to identify mortality predictors/risk 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.
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 morbidity.The aim of this study was to identify mortality predictors/risk 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 injury/hemorrhage 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 and/or control of
intracranial pressure performed by neurosurgery department were taken into consideration for
analysis.
In all patients, diagnosis was made based on CT scan and/or MR imaging study obtained at
arrival to emergency department as a part of emergency protocol.
