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IRCT20200429047242N1 IRCT 2020-06-27 Esfahan University of Medical Sciences A comparative study on the effect of the two methods of pressure support setting on the respiratory distress in patients undergoing mechanical ventilation admitted in intensive care units A comparative study on the effect of two methods of pressure support setting on the respiratory distress in patients undergoing mechanical ventilation admitted in intensive care units 2020-06-04 anticipated 56 Complete https://irct.ir/trial/47961 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are divided into two groups using minimization software. Age, sex, body mass index, analgesic use, sedative use, APACHE IV index rate and PEEP rate are given to minimization software to divide patients into two groups. Minimization (or Minimizer) is the name of a software used to divide samples among groups in clinical trials. In research projects, there are always variables that may affect the accuracy of the study (confounder variables); By entering these variables in this software, the variables are distributed among the research groups in such a way that there is the least difference between the groups, and for this reason, this method is preferable to the randomization method.This software has been installed on the website of Isfahan University of Medical Sciences at http://rct.mui.ac.ir/q/index.php; In this research we will use this website too, Blinding description: This study is double blind because in this study, the researcher (data collector and outcome assessor) first fill in the first part of the questionnaire and then the researcher's coworker (clinical caregiver; anesthesiologist) enters the data into the minimization software and then he sets pressure support by RSBI or " tidal volume and respiratory rate" method. The researcher fills the second and third parts of the questionnaire 15 and 30 minutes after setting the pressure support. The participant (patient), the researcher (data collector and outcome assessor) and the data analyst are not aware of how the samples are categorized. The draft of the article is prepared by the researcher too. N/A patients under mechanical ventilation. Intervention 1: Intervention group: In this group, pressure support is adjusted to the extent that the patient's rapid shallow breathing index is less than 105 breaths per minute per liter, because when this index is less than 105, the patient does not have rapid and shallow breathing (respiratory distress) and this means that the pressure support is properly adjusted for the patient. Intervention 2: Control group: In this group, the adjustment of pressure support is based on tidal volume and number of breaths. Pressure support is adjusted to the extent that the patient's breathing rate is less than 30 and his or her tidal volume is more than 4-8 ml / kg, because in this case the patient does not have respiratory distress; this means that the patient's pressure support is set correctly. 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 There is no more information
public Somayeh Ghafari
Nursing and midwifery faculty, Isfahan university of medical sciences, Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673465 +98 31 3792 7540 somayehghafari@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Somayeh Ghafari
Nursing and midwifery faculty, Isfahan university of medical sciences, Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673465 +98 31 3792 7540 somayehghafari@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients have to be under mechanical ventilation (SPONT mode); The overall respiratory rate of the patients (breath which are delivered by the ventilator and spontaneous breath) must be more than 30 breaths per minute and the tidal volume of patient's breath have to be less than 4-8 ml/kg The rapid shallow breathing index(RSBI) of the patients must be more than 105 breaths per minute per liter Patients must be adult The patient's respiratory distress observation scale must be more than 3 18 years no limit Both Chronic obstructive pulmonary disease and acute respiratory distress syndrome Use of neuromuscular blocking drugs Treatment - Devices Treatment - Devices Intervention group: In this group, pressure support is adjusted to the extent that the patient's rapid shallow breathing index is less than 105 breaths per minute per liter, because when this index is less than 105, the patient does not have rapid and shallow breathing (respiratory distress) and this means that the pressure support is properly adjusted for the patient. Control group: In this group, the adjustment of pressure support is based on tidal volume and number of breaths. Pressure support is adjusted to the extent that the patient's breathing rate is less than 30 and his or her tidal volume is more than 4-8 ml / kg, because in this case the patient does not have respiratory distress; this means that the patient's pressure support is set correctly. Signs and indicators of respiratory distress. Timepoint: before setting the pressure support, 15 and 30 minutes after setting it. Method of measurement: respiratory distress observation scale, rapid shallow breathing index(RSBI). Esfahan University of Medical Sciences Approved 2020-04-15 Ethics committee of Isfahan University of Medical Sciences Nursing and midwifery faculty, Isfahan university of medical sciences, Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)