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IRCT20190325043107N38 IRCT 2023-11-25 Tabriz University of Medical Sciences Comparison of early and late tracheostomy in the outcome of intubated patients Comparison of early and late tracheostomy in the outcome of multitrauma intubated patients 2023-12-19 anticipated 80 Complete https://irct.ir/trial/73467 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they were divided into two intervention groups (group A) and control group (group B), Blinding description: The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. 1-2 Successful weaning from mechanical ventilation. Intervention 1: Intervention group: Patients will undergo surgery by early tracheostomy after random allocation in the mentioned group. Early tracheostomy is defined as performing tracheostomy during the first seven days of mechanical ventilation. The success rate of weaning from mechanical ventilation for these patients will be recorded. Intervention 2: Control group: Patients will be subjected to late tracheostomy surgery after random allocation in the mentioned group. Late tracheostomy is defined as performing tracheostomy after the first seven days of mechanical ventilation. The success rate of weaning from mechanical ventilation for these patients will be recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Trauma patients Duration of ventilation more than 48 hours Estimated duration of mechanical ventilation by the doctor at least more than 21 days 18 years 65 years Both Severe injuries to the chest or neck Burns in the neck Drowning patients Z93.0 Tracheostomy status Prevention Prevention Intervention group: Patients will undergo surgery by early tracheostomy after random allocation in the mentioned group. Early tracheostomy is defined as performing tracheostomy during the first seven days of mechanical ventilation. The success rate of weaning from mechanical ventilation for these patients will be recorded. Control group: Patients will be subjected to late tracheostomy surgery after random allocation in the mentioned group. Late tracheostomy is defined as performing tracheostomy after the first seven days of mechanical ventilation. The success rate of weaning from mechanical ventilation for these patients will be recorded. Weaning from mechanical ventilation. Timepoint: Once during the study. Method of measurement: Clinical observation. Tabriz University of Medical Sciences Approved 2023-04-16 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)