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IRCT20161124031068N2 IRCT 2018-10-20 Tehran University of Medical Sciences Comparison the effect of distilled water and normal saline on hemodynamic parameters and ventilator associated pneumonia Comparison the effect of distilled water and normal saline instillation during endotracheal suctioning on hemodynamic parameters and ventilator associated pneumonia among patients under mechanical ventilation 2017-11-22 anticipated 60 Complete https://irct.ir/trial/32541 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block balanced randomization method will be used. Randomization sequence will be generated by free website available from: www.randomization.com. In order to determine the randomization sequence in this website, 4 subjects in each block will be considered. Thus, by considering letter A for control group and letter B for intervention group, randomization sequence will be generated for 21 blocks. For random allocation concealment, cards containing blocks will be inserted in standard envelopes. In order to determine the allocation group, one envelope will be taken randomly by the researcher after shuffling, Blinding description: All cultures related to the patients will be sent to laboratory. However, laboratory staffs prepared the culture would not be aware of the allocation groups. N/A Ventilator associated pneumonia (VAP). Intervention 1: Intervention group: Instillation of 3 to 5 cc of distilled water (Samen company, Iran) in the trachea before endotracheal suctioning for 5 continuous days by nurse. Intervention 2: Control group: Instillation of 3 to 5 cc of normal saline (Samen company, Iran) in the trachea before endotracheal suctioning for 5 continuous days by nurse. Yes - There is a plan to make this available What will be shared: After making data unrecognizable, all data will be shared. When: Starting in January 2020 To whom: It will be available for researchers working in academic institutions. Conditions: For people that have academic education and these data can be useful for their research. Where to obtain: Maryam Shafei; maryam_nursing@yahoo.com How to obtain: email to "maryam_nursing@yahoo.com" and comment that why he/she wants to access to these data Comments:
public Maryam Esmaeili
No. 123, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
Tehran Iran (Islamic Republic of) 1419733117 +98 21 6692 7171 Esmaeiliem@yahoo.com Tehran University of Medical Sciences scientific Maryam Esmaeili
No. 123, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
Tehran Iran (Islamic Republic of) 1419733117 +98 21 6692 7171 Esmaeiliem@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Negative culture of the trachea at the beginning of intubation Systolic blood pressure more than 90 mmHg without administration of inotropic drugs Normal level of electrolytes Without cardiac arrhythmia Urinary output more than 30 cc per hour Without asthma Without chronic obstructive pulmonary disease Without lung infections no limit no limit Both With previous asthma With previous chronic obstructive pulmonary disease With previous lung infections J95.851 Ventilator associated pneumonia Prevention Prevention Intervention group: Instillation of 3 to 5 cc of distilled water (Samen company, Iran) in the trachea before endotracheal suctioning for 5 continuous days by nurse Control group: Instillation of 3 to 5 cc of normal saline (Samen company, Iran) in the trachea before endotracheal suctioning for 5 continuous days by nurse Ventilatore associated pneumonia. Timepoint: Before intervention and 5 days after intervention. Method of measurement: Endoteracheal culture. Blood pressure. Timepoint: Before and 5 minutes after endotracheal suctioning. Method of measurement: Vital-signs monitoring device. Heart rate. Timepoint: Before and 5 minutes after endotracheal suctioning. Method of measurement: Vital-signs monitoring device. Respiratory rate. Timepoint: Before and 5 minutes after endotracheal suctioning. Method of measurement: Vital-signs monitoring device. Peripheral blood oxygen saturation (SpO2). Timepoint: Before and 5 minutes after endotracheal suctioning. Method of measurement: pulse oximeter. Tehran University of Medical Sciences Approved 2017-12-16 Ethics committee of Tehran University of Medical Sciences No. 123, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town, Tehran Tehran Iran (Islamic Republic of)