]>
IRCT20181018041376N1 IRCT 2019-02-23 Shahroud University of Medical Sciences The Effectiveness of Pressure and Volumetric Ventilation Modes on the Cuff Pressure of Endotracheal Tube and Air Leakage Comparison of the Effectiveness of Pressure and Volume controlled Ventilation on the Intracuff Pressure and Air Leakage around the Cuff of the Endotracheal Tube in anesthetized and Mechanically ventilated Patients 2019-03-21 anticipated 50 Complete https://irct.ir/trial/34684 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are selected based on Entry and Exit Criteria. After Obtaining informed Consent from the Patients, they are assigned to the Two Groups of p and v Using the Random quadratic Block Method. In this Method, a Table of 50 Letters of the Letters p and v is prepared and then, to observe the Random Allocation Hiding, each of These Letters is enclosed in a sealed Envelope, Respectively. After Closing the Door, each Envelope on it is numbered, in the Order of the original Table. After Selecting a qualified Patient, the Envelope for that Patient is opened and, based on the Letters inside, the Patient is assigned to one of the Two Groups, Blinding description: This Research is a Triple blind Study. The Patients Undergoing general Anesthesia prior to the Intervention and are blinded. The trained Person who measures the Cuff Pressure and Air Leakage is blinded by Covering the Ventilator and uncertain Ventilator Mode. The Data Analyzer is blinded by the Coding of the Two Study Groups (P and v) to the Groups (A and B). N/A Changes in Cuff Pressure and Air Leakage around the Endotracheal Tube. Intervention 1: Intervention: In Group P (Intervention), after Connecting the Patient to the Ventilator, the Pcv Mode (as an Intervention of this Study) will be used for Mechanical Ventilation during Anesthesia. This Mode is set on the Ventilator and the Airway Pressure is adjusted to reach a Tidal Volume of 7ml / kg. Intervention 2: Control group: In Group v (Control), the Routine Method is used for Mechanical Ventilation of Patients during Anesthesia. In this Group of Patients, vcv Mode, which is a Routine Ventilation Mode, will be activated on the Ventilator and the Tidal Volume of 7 ml / kg will be adjusted on the Ventilator. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Shahram Nasrollahzade
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
Shahroud Iran (Islamic Republic of) 3617753917 +98 23 3239 3811 nasrolahzadeh@shmu.ac.ir Shahroud University of Medical Sciences scientific Javad Nourian
Shahroud University of Medical Scienses, Hafte-Tir Sq., Tehran Street
Shahroud Iran (Islamic Republic of) 6314773955 +98 23 3239 3811 javadnourian@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 40 Years old and Ready for open-cut Surgery and Inguinal Hernia in supine Position (Patients in Class 1 & 2 Anesthetic Classification for Surgery) ASA 1&2 BMI=18-24 18 years 40 years Both Smoking and Drug Use Treatment - Devices Treatment - Devices Intervention: In Group P (Intervention), after Connecting the Patient to the Ventilator, the Pcv Mode (as an Intervention of this Study) will be used for Mechanical Ventilation during Anesthesia. This Mode is set on the Ventilator and the Airway Pressure is adjusted to reach a Tidal Volume of 7ml / kg. Control group: In Group v (Control), the Routine Method is used for Mechanical Ventilation of Patients during Anesthesia. In this Group of Patients, vcv Mode, which is a Routine Ventilation Mode, will be activated on the Ventilator and the Tidal Volume of 7 ml / kg will be adjusted on the Ventilator. Changes in Intracuff Pressure of the Endotracheal Tube. Timepoint: At the Beginning of the Study (before the Intervention) and 10, 20 and 30 Minutes after Applying the Volume controlled or Pressure controlled Ventilation Mode on the Ventilator. Method of measurement: Using the German VBM Manometer (with a Measurement Range of 0-120 CmH2o). Co2 Leakage Changes (as an Indicator of Air Leakage) around the Cuff of the Endotracheal Tube. Timepoint: Measuring the aAmount of Co2 in the Supraglutic Space at the Beginning of the Study (before the Intervention) and 10, 20, and 30 Minutes after Applying the Ventilation Mode, volume controlled or pressure controlled on the Ventilator. Method of measurement: Using the Sazgan Gostar Capnograph, in the Superglot Space will be measured. Shahroud University of Medical Sciences Approved 2018-12-30 Ethics Committee of Shahroud Univercity of Medical Sciences Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street Shahroud Semnan Iran (Islamic Republic of)