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IRCT20181105041565N1 IRCT 2019-04-23 Islamic Azad University Impact of cooling on patients with acute stroke Impact of hypothermia on final outcome of patients with acute stroke: a randomized clinical trial 2018-07-01 anticipated 70 Complete https://irct.ir/trial/35105 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: A study is a randomized controlled trial with control group. The intervention only is done on experimental group and the control group received routine treatment, Randomization description: Cluster random sampling method will be used for sampling. Thus, from among 12 hospitals in Hamadan province, clusters from the internal and ICU wards will be randomly selected and the number of samples will be selected based on the number of hospitalized patients. Then, by simple random sampling method using by random numbers software, the samples will be assigned to the control and experimental groups and finally the samples of the two groups will be homogenized in terms of individual characteristics, Blinding description: Hiding the allocation of patients to the control and test group Not knowing the executives and people involved in analyzing the data from the control and experimental groups. N/A stroke. Intervention 1: Intervention group: Group A, that hypothermia is performed through the cooling device (Helmets) which is placed on the patient's head. Intervention 2: Control group: Group B that patients receive routine care and no intervention is performed. No - There is not a plan to make this available Justification or reason for not sharing IPD is Not disclosing private information of participants
public Abbas Rozbahani
Islamic Azad University of Urmia, Salmas road, Urmia Town
Uromieh Iran (Islamic Republic of) 5716963896 +98 44 3272 2045 abbas.rozbahanaa@yahoo.com Islamic Azad University scientific Abbas Rozbahani
Islamic Azad University of Urmia, Salmas road, Urmia Town
Urmia Iran (Islamic Republic of) 5716963896 +98 44 3272 2045 abbas.rozbahanaa@yahoo.com Islamic Azad University Iran (Islamic Republic of) Having a hemorrhagic or ischemic stroke Age over 18 years old Informed consent form signed by the patient or his/her representative Not having severe heart failure - Grade 2 and 3 based on cardiologist diagnosis Absence of pulmonary embolism or acute myocardial infarction Absence of any cardiac arrhythmia or ventricular or atrioventricular block in the ECG Absence of acute or chronic sinusitis or current skull bone fracture Not getting septicemia or bacteremia or severe blood infection at the admission time Not having fever above 38.5 ° C when admitted Absence of known blood diseases with increase the risk of thrombosis such as cryoglobulinemian, cold agglutination, or sickle cell anemia Absence of known spastic venous complications, such as Raynaud's disease, or thromboangiitis obliterans Weight less than 120 kg 18 years 90 years Both Death in less than 24 hours after admission Patient or legal guardian requisition for leaving the study Incidence of unwanted side effects includes intolerance, seizure, shivering, or physician discretion Incidence of cardiac dysrhythmias G46 Vascular syndromes of brain in cerebrovascular diseases Treatment - Other Other Intervention group: Group A, that hypothermia is performed through the cooling device (Helmets) which is placed on the patient's head. Control group: Group B that patients receive routine care and no intervention is performed. Level of patient alertness. Timepoint: A 72-hour period. Method of measurement: FOUR Score Scale: A tool that measures patient's alertness and level of consciousness. Predict the patient's recovery rate. Timepoint: A 72-hour period. Method of measurement: APACHE Scale that is used to measure the prognosis and recovery rate of the patients in critical care unit. Health level of patients. Timepoint: A 72-hour period. Method of measurement: The NIHSS scale a tool is used to health level of patients with stroke. Islamic Azad University Approved 2018-10-15 Ethics Committee of Islamic Azad University, Urmia Branch Islamic Azad University., Urmia branch .,Salmas Road .,Orumieh Orumieh West Azarbaijan Iran (Islamic Republic of)