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IRCT20190510043545N3 IRCT 2023-11-06 Mashhad University of Medical Sciences the effect of ventilator settings on diaphragm atrophy the effect of ventilator settings based on diaphragm thickening fraction on diaphragm atrophy 2023-11-21 anticipated 40 Complete https://irct.ir/trial/69304 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Random allocation rule is the simplest method of limited randomization. This method represents a large block for the entire sample size, which means that the balance in the number of people allocated to each group will be achieved at the end of the study. For this purpose, the researchers first determined a total sample size (40 people) and then randomly assigned groups of them to group A and the rest to group B. For example, in a study with a sample size of 40 people, 20 balls for the intervention group A and 20 balls for the control group B are placed in a lottery container, and then the balls are randomly removed from the container without replacement and the created sequence is recorded. It should be noted that random sequence generation will be done through randomization.com Allocation Concealment: Sealed envelopes Randomization Unit: Individual, Blinding description: In this study, the researcher and the outcome evaluator do not know the group in which the patients are located. In this study, the data analyst does not know the group in which the patients are located. N/A Diaphragm atrophy. Intervention 1: Intervention group: In the normal settings of the ventilator on pcv (pressure control ventilation) mode, the ventilator is set based on DTF. If the DTF (diaphragm thickening fraction) is above 30%, the inspiratory pressure increases, and if it is less than 15%, the inspiratory pressure decreases. In this study, in the intervention group, diaphragm ultrasonography is performed every day and DTF is calculated, if the DTF is above 30%, in the same interval, the tidal volume is created at 6 to 8 cc/kg; Increased inspiratory pressure (settings tend to 8 cc/kg) and if the DTF is less than 15%, in the same range; Inspiratory pressure decreases. (settings tend to 6 cc/kg). Intervention 2: Control group: The control group uses the usual settings of the ventilator. In the usual settings of the ventilator in the PCV mode (pressure control ventilation ) , the inspiratory pressure is set so that the patient has a tidal volume between 6 and 8 ml/kg. And the peak inspiratory pressure should not increase from 30 h2o cm. Yes - There is a plan to make this available What will be shared: Information about the outcomes of the study is published in a research paper When: At the same time as the article is published To whom: Researchers working in academic and scientific institutions Conditions: Analysis for review articles and meta-analysis Where to obtain: Correspond to this email: sjvdpurafzali@yahoo.com How to obtain: These items should be clearly explained in the requested email: - How to use information - The details of the research that wants to use this information. - Detailed information of the applicant After reviewing these items, an answer will be given immediately Comments:
public Seyed Javad Purafzali Firuzabadi
Imam Reza hospital-Imam Reza Square, Ibn-e Sina Avenue, Mashhad - Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 936 624 9277 sjvdpurafzali@yahoo.com Mashhad University of Medical Sciences scientific Seyed Javad Purafzali Firuzabadi
Imam Reza hospital-Imam Reza Square, Ibn-e Sina Avenue, Mashhad - Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 936 624 9277 sjvdpurafzali@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Over 18 years with informed consent (from family) The patient has been intubated in the last 24 hours. be on (pressure controlled ventilator mode). 18 years no limit Both Absence of underlying diseases (like: lung disease, myopathy, brain disease, connective tissue disease) No poisoning with things that cause muscle paralysis. J95.850 Mechanical complication of respirator Prevention Prevention Intervention group: In the normal settings of the ventilator on pcv (pressure control ventilation) mode, the ventilator is set based on DTF. If the DTF (diaphragm thickening fraction) is above 30%, the inspiratory pressure increases, and if it is less than 15%, the inspiratory pressure decreases. In this study, in the intervention group, diaphragm ultrasonography is performed every day and DTF is calculated, if the DTF is above 30%, in the same interval, the tidal volume is created at 6 to 8 cc/kg; Increased inspiratory pressure (settings tend to 8 cc/kg) and if the DTF is less than 15%, in the same range; Inspiratory pressure decreases. (settings tend to 6 cc/kg) Control group: The control group uses the usual settings of the ventilator. In the usual settings of the ventilator in the PCV mode (pressure control ventilation ) , the inspiratory pressure is set so that the patient has a tidal volume between 6 and 8 ml/kg. And the peak inspiratory pressure should not increase from 30 h2o cm. Diaphragm Thickness. Timepoint: daily for 3 days. Method of measurement: Ultrasonography. Diaphragm thickening fraction. Timepoint: Daily for 3 days. Method of measurement: Ultrasonography. Mashhad University of Medical Sciences Approved 2023-02-28 Ethics committee of Mashhad University of Medical Sciences Imam Reza hospital-Imam Reza Square, Ibn-e Sina Avenue, Mashhad - Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)