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IRCT20190215042716N5 IRCT 2023-12-20 Shahid Beheshti University of Medical Sciences Evaluation of movement and thickness of diaphragm measured by ultrasound on weaning success in patients admitted to Intensive Care Unit Evaluation of movement and thickness of diaphragm measured by ultrasound on weaning success in patients admitted to Intensive Care Unit 2023-12-22 anticipated 60 Complete https://irct.ir/trial/74331 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After initial screening and selecting 60 eligible patients based on the inclusion and exclusion criteria, their baseline and demographic information will be recorded. The APACHE II and SOFA scores of the patients will be calculated to determine the severity of their illness. The patients will be compared in terms of illness severity, and 30 patients with similar severity will be placed in group A and 30 other patients with similar severity in group B. Then, using a random number generation software, group A will be selected as the intervention group and group B as the control group. This is how patients will be randomly allocated to the two 30-people intervention and control groups. Finally, the intervention will be applied to the intervention group and the results will be compared with the control group, Blinding description: This study is designed as a double-blinded randomized clinical trial. This means that not only are the patients unaware of their allocation to either the intervention or control group, but the treating physicians and nurses are also blinded to the patient allocation .Therefore, neither the patient nor the treating physician/nurse know which group the patient is allocated to. This is done to eliminate bias in the results. 2-3 weaning of mechanical ventilation. Intervention 1: Intervention group: The intervention group includes 30 eligible patients who are randomly selected. In addition to standard methods for assessing readiness for extubation (e.g. RSBI index), patients in the intervention group undergo diaphragmatic ultrasonography performed by the study investigator (anesthesia resident). In the diaphragmatic ultrasound, the movement and thickness of the diaphragm are measured in M-mode. The findings from the diaphragmatic ultrasound serve as the basis for deciding whether the patient is ready for extubation. Intervention 2: Control group: The control group contains 30 patients similar to the intervention group in terms of demographic characteristics and illness severity, selected randomly. In this group, patients receive standard existing care in the ICU and diaphragmatic ultrasonography is not performed. The criteria for deciding on extubation is also based on standard methods. Yes - There is a plan to make this available What will be shared: The whole potential data after being unidentifiable is published When: One year To whom: Medical Society Conditions: Letter from the studied university Where to obtain: Email: n.shafigh@sbmu.ac.ir How to obtain: Registration of applications and letters from the university and review and presentation of information within one month Comments:
public Navid Shafigh
N0.15, 26 Ave ,27 Ave, Kordestan Blvd , Tehran Yown
Tehran Iran (Islamic Republic of) 13413825627 +98 21 8801 3378 n.shafigh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Navid Shafigh
N0.15, 26 Ave ,27 Ave, Kordestan Blvd , Tehran Yown
Tehran Iran (Islamic Republic of) 13413825627 +98 21 8801 3378 n.shafigh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Admitted to ICU due to respiratory failure Under mechanical ventilation Meeting the extubation criteria 18 years 80 years Both Having neuromuscular disease Presence of pleural effusion Decreased level of consciousness T88.4 Failed or difficult intubation Treatment - Devices Treatment - Devices Intervention group: The intervention group includes 30 eligible patients who are randomly selected. In addition to standard methods for assessing readiness for extubation (e.g. RSBI index), patients in the intervention group undergo diaphragmatic ultrasonography performed by the study investigator (anesthesia resident). In the diaphragmatic ultrasound, the movement and thickness of the diaphragm are measured in M-mode. The findings from the diaphragmatic ultrasound serve as the basis for deciding whether the patient is ready for extubation Control group: The control group contains 30 patients similar to the intervention group in terms of demographic characteristics and illness severity, selected randomly. In this group, patients receive standard existing care in the ICU and diaphragmatic ultrasonography is not performed. The criteria for deciding on extubation is also based on standard methods. Main outcome measures including rates of successful extubation, duration of extubation and ICU length of stay will be compared between the two groups. Timepoint: one weak. Method of measurement: sonography. Shahid Beheshti University of Medical Sciences Approved 2023-11-22 Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)