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IRCT20210209050307N1 IRCT 2021-03-13 Rafsanjan University of Medical Sciences Effect of Head Cooling and Remote Conditioning in Traumatic Brain Injury Effect of Head Cooling and Remote Conditioning in Limb on outcome of patients with Traumatic Brain Injury 2021-04-04 anticipated 84 Recruiting https://irct.ir/trial/54222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients enter the groups randomly after visiting the emergency department. Patients who enter the hospital consecutively enter the study groups in order. Randomization is block type and people enter the hospital in the first, second, third or fourth block, respectively, Blinding description: After diagnosing the disease, the treating physician does not know the patient's entry into the desired group and the type of treatment, and also the patient has no information about the intervention and treatment. 2-3 Traumatic Brain Injury. Intervention 1: Intervention group 1: There is no intervention on them. Intervention 2: Intervention group 2: Head cooling group: Hypothermia caps are usually made of synthetic materials such as neoprene, silicone or polyurethane and are cooled with a cooling agent such as ice and gel that can be cooled to -25 to -30 degrees Celsius before use. For repeated use of the caps, they are filled with krillon gel, which freezes up to -30 degrees Celsius. As the caps warm up during use, several ice caps are prepared, which must be replaced with a new, completely frozen ice cap every 20 to 30 minutes after use. In groups with ice caps, treatment is started immediately after admission. It is used for the first three consecutive days after admission for 0 to 6 hours (average 4.5 hours) depending on the patient's condition and tolerance to maintain the brain temperature at 33 to 34 degrees Celsius. The researcher measures the temperature of the brain with a tympanic membrane thermometer (the difference between the temperature of the tympanic membrane and the temperature of the brain is about 0.2 degrees Celsius). For this purpose, the brain temperature is likely to drop to about 33 to 34 degrees Celsius (it takes about 2 hours) and is maintained in the same range. Intervention 3: Intervention group 3: RIC Technique Group: Arm ischemia is a full 5-minute full blood pressure cuff and a 5-minute empty blood pressure cuff in which the cuff is filled to 200 mm Hg or the patient's systolic pressure plus 25 mm Hg. This will be done at the same time as putting on the ice cap in the golden hours after the injury. Intervention 4: Intervention group 4: Head cooling group and RIC technique. No - There is not a plan to make this available Justification or reason for not sharing IPD is We are currently deciding to publish an article.
public Amir moghadamahmadi
Abozar 1/1
Rafsanjan Iran (Islamic Republic of) 7719794454 +98 34 3423 4191 a.moghadamahmadi@gmail.com Rafsanjan University of Medical Sciences scientific a.moghadamahmadi@gmail.com
abozar1/1
Rafsanjan Iran (Islamic Republic of) 7719794454 +98 34 3423 4191 a.moghadamahmadi@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Glawsco Coma Scale (GCS) score of less than 8 14 years 65 years Both presence of known inflammatory disorder history of neurological or psychological disorders dependence to drugs or opium mild Traumatic Brain Injury (TBI) signs of disseminated injury without mass effect on brain Computed Tomography (CT) scan image Diagnosis Treatment - Devices Treatment - Other Treatment - Devices Intervention group 1: There is no intervention on them Intervention group 2: Head cooling group: Hypothermia caps are usually made of synthetic materials such as neoprene, silicone or polyurethane and are cooled with a cooling agent such as ice and gel that can be cooled to -25 to -30 degrees Celsius before use. For repeated use of the caps, they are filled with krillon gel, which freezes up to -30 degrees Celsius. As the caps warm up during use, several ice caps are prepared, which must be replaced with a new, completely frozen ice cap every 20 to 30 minutes after use. In groups with ice caps, treatment is started immediately after admission. It is used for the first three consecutive days after admission for 0 to 6 hours (average 4.5 hours) depending on the patient's condition and tolerance to maintain the brain temperature at 33 to 34 degrees Celsius. The researcher measures the temperature of the brain with a tympanic membrane thermometer (the difference between the temperature of the tympanic membrane and the temperature of the brain is about 0.2 degrees Celsius). For this purpose, the brain temperature is likely to drop to about 33 to 34 degrees Celsius (it takes about 2 hours) and is maintained in the same range. Intervention group 3: RIC Technique Group: Arm ischemia is a full 5-minute full blood pressure cuff and a 5-minute empty blood pressure cuff in which the cuff is filled to 200 mm Hg or the patient's systolic pressure plus 25 mm Hg. This will be done at the same time as putting on the ice cap in the golden hours after the injury Intervention group 4: Head cooling group and RIC technique APACHE II scores. Timepoint: 72 hours -6 days- 2 months later. Method of measurement: questionnaire. Rafsanjan University of Medical Sciences Approved 2016-05-17 Ethics committee of Rafsanjan University of Medical Sciences Emam Ali street Rafsanjan Kerman Iran (Islamic Republic of)