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IRCT20180108038267N1 IRCT 2018-02-23 Esfahan University of Medical Sciences comparing two close suction and open suction method in patients under mechanical ventilation in intensive care units Investigating and comparing the effects of open and closed tracheal suction system on the pain and respiratory indicators in patients under mechanical ventilation in intensive care units 2017-04-21 anticipated 70 Complete https://irct.ir/trial/28909 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients eligible for the research will be selected by simple method and then, using Minimization software, are divided into two open and closed suction groups. This software, based on the variables of sex, age, BMI, and spo2, divides the patients into two open and closed suction groups in such a way that the groups have the least difference, Blinding description: Open and closed suction are performed by the researcher and the data is recorded by the researcher's colleague who is one personnel of ICU and, hence, the researcher is not aware of the recorded data. N/A patients under mechanical ventilation in intensive care units. Intervention 1: Intervention group: For the intervention group, closed suction is performed while the patient is connected to a mechanical ventilator due to the need of patient, by the researcher according to the 2014 protocol. Respiratory Indicators including respiratory rate, arterial oxygen saturation, minute ventilation, static and dynamic compliance and pain recorded by monitoring and pain assessment tool are registered in the data collection form by a researcher before, 10 minutes and thirty minutes after suctioning. Intervention 2: Control group: The open suction is done by removing the patient from the ventilator by the researcher according to the 2014 protocol. Respiratory Indicators including respiratory rate, arterial oxygen saturation, minute ventilation, static and dynamic compliance and pain recorded by monitoring and pain assessment tool are registered in the data collection form by a researcher before, 10 minutes and thirty minutes after suctioning. No - There is not a plan to make this available Justification or reason for not sharing IPD is No plan has been considered yet to publish the results. There is no further information.
public Fatemeh Khaier
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7544 ftmkhaier@gmail.com Esfahan University of Medical Sciences scientific Somayeh Ghafari
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7544 somayehghafari@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) admission to the ICU of the hospital Being at the age of 18-70 years no history of cardiac diseases no primary pulmonary pathophysiology ventilation with Synchronized Intermittent Mandatory Ventilation (SIMV) Positive End Expiratory Ventilation (PEEP)=3-5 cm H2O Tidal Volume(TV)=8 – 10 ml/kg Fractional Inspired Oxygen(FIO2)=40% to 60% Pressure Support Ventilation (PSV)=8 -10 cm no coagulation disorder or thrombocytopenia Richmond Agitation Sedation Scale (RASS) =0,-1 18 years 70 years Both hemodynamic instability (in systolic blood pressure (SBP) less and greater than 20 mmHg and in diastolic blood pressure (DBP) less and greater than 20 mmHg) having cardiac arrhythmia Treatment - Devices Treatment - Devices Intervention group: For the intervention group, closed suction is performed while the patient is connected to a mechanical ventilator due to the need of patient, by the researcher according to the 2014 protocol. Respiratory Indicators including respiratory rate, arterial oxygen saturation, minute ventilation, static and dynamic compliance and pain recorded by monitoring and pain assessment tool are registered in the data collection form by a researcher before, 10 minutes and thirty minutes after suctioning. Control group: The open suction is done by removing the patient from the ventilator by the researcher according to the 2014 protocol. Respiratory Indicators including respiratory rate, arterial oxygen saturation, minute ventilation, static and dynamic compliance and pain recorded by monitoring and pain assessment tool are registered in the data collection form by a researcher before, 10 minutes and thirty minutes after suctioning. Patient's level of pain. Timepoint: Before the suction, during the suction, ten minutes and thirty minutes after the suction. Method of measurement: CPOT scale. Respiratory indicators. Timepoint: Before the suction, ten minutes and thirty minutes after the suction. Method of measurement: Monitoring of patient-ventilator. Esfahan University of Medical Sciences Approved 2016-02-21 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)