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IRCT20230907059376N1 IRCT 2023-09-13 Afridi Medical Complex, Peshawar Controlled decompression effects in the patients with severe TBI: A Randomized Control Trial Controlled decompression effects in the patients with severe TBI: A Randomized Control Trial 2022-08-13 anticipated 52 Complete https://irct.ir/trial/72532 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In our trial, randomization was conducted using a computer-generated random sequence that allocated participants into one of two groups: controlled decompression or fast decompression, following Traumatic Brain Injury (TBI) prior to surgery. This randomization process ensured that each participant had an equal and unbiased chance of being assigned to either group, minimizing potential selection bias and allowing for a more reliable assessment of the treatment outcomes. N/A Traumatic brain injury. Intervention 1: Intervention group: Standard surgical techniques were used to achieve a rapid craniotomy.The dura was entirely opened by a normal large craniotomy (12 to 15 cm), allowing the ICP to be quickly, totally, and uncontrollably discharged. ICP monitoring was given to each patient in this group. The intraoperative surgical approach did not take the ICP into account, and the rate of ICP decline was not managed during the procedure. The fast removal of the hematoma and brain contusion tissue was the main objective of the procedure. Intervention 2: Control group: The goal of controlled decompression was to guarantee that the ICP would gradually release over the whole treatment using a variety of techniques. ICP dropped at a rate of 10-15 mmHg per 10 minutes. Before the craniotomy, an ICP probe was implanted to get the initial ICP. The best option was a brain tissue monitor, followed by a ventricular intracranial pressure monitor. Cerebrospinal fluid (CSF) was gradually discharged until the ICP was > 40 mmHg if the initial ICP was greater than that value. Second, to pressurize the brain and prevent a sharp drop in ICP after the bone was removed, a craniotomy with a bone window (12 ×15 cm) was necessary. Third, a small incision no bigger than 5 mm, which is frequently the diameter of the aspirator head, was used to breach the dura. The ICP was steadily decreased while the hematoma and brain contusion tissue were carefully aspirated. The dura was completely opened, and the hematoma or brain contusion tissue was then removed when the ICP was less than 10 mmHg and there were no visible evidence of bulging brain tissue. Yes - There is a plan to make this available What will be shared: Controlled decompression effects in the patients with severe TBI: A Randomised Control Trial When: Next year To whom: Neuro surgeon Conditions: Through email Where to obtain: Contacting Principal author through email How to obtain: Contact Principal author Dr Mhaboob through email. Email of the author is: mehbob509@gmail.com Comments:
public Abdul Hameed Khan
Sharoe Green Ln, Fulwood, Preston PR2 9HT, UK
Preston United Kingdom of Great Britain and Northern Ireland PR2 9HT +44 1772 716565 drhameedkhan@gmail.com Royal Preston Hospital, Preston UK scientific Mahboob Khan
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25150 +92 91 5711751 mehboob509@gmail.com Afridi Medical Complex, Peshawar Pakistan Patients with TBI between the ages of 18 and 75 Patients who gave informed permission Glasgow Coma Scale (GCS) score between 3 and 8 at admission 18 years 75 years Both Initial need for bilateral craniotomy Preoperative GCS score of 3 with no improvement after treatment in the emergency room Presentation without attenuated respiration and blood pressure Combination of anoxia and hypotension with brain swelling caused by anoxia or hypotension and minor intracranial bleeding after injury Coagulation disorder or a history of aspirin intake and multiorgan malfunction S06.2 Diffuse traumatic brain injury Treatment - Surgery Treatment - Surgery Intervention group: Standard surgical techniques were used to achieve a rapid craniotomy.The dura was entirely opened by a normal large craniotomy (12 to 15 cm), allowing the ICP to be quickly, totally, and uncontrollably discharged. ICP monitoring was given to each patient in this group. The intraoperative surgical approach did not take the ICP into account, and the rate of ICP decline was not managed during the procedure. The fast removal of the hematoma and brain contusion tissue was the main objective of the procedure. Control group: The goal of controlled decompression was to guarantee that the ICP would gradually release over the whole treatment using a variety of techniques. ICP dropped at a rate of 10-15 mmHg per 10 minutes. Before the craniotomy, an ICP probe was implanted to get the initial ICP. The best option was a brain tissue monitor, followed by a ventricular intracranial pressure monitor. Cerebrospinal fluid (CSF) was gradually discharged until the ICP was > 40 mmHg if the initial ICP was greater than that value. Second, to pressurize the brain and prevent a sharp drop in ICP after the bone was removed, a craniotomy with a bone window (12 ×15 cm) was necessary. Third, a small incision no bigger than 5 mm, which is frequently the diameter of the aspirator head, was used to breach the dura. The ICP was steadily decreased while the hematoma and brain contusion tissue were carefully aspirated. The dura was completely opened, and the hematoma or brain contusion tissue was then removed when the ICP was less than 10 mmHg and there were no visible evidence of bulging brain tissue. Global disability and recovery after traumatic brain injury. Timepoint: Baseline and after 6 months. Method of measurement: Extended Glasgow Outcome Scale (GOSE). Afridi Medical Complex, Peshawar Approved 2022-07-13 Afridi Medical Complex ethical committee Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa Peshawar Khyber Pakhtunkhwa Pakistan