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IRCT20121107011398N15 IRCT 2022-01-03 Iran University of Medical Sciences Comparison of pressure versus volume control ventilation in one lung ventilation Comparison of the effect of two Pressure and Volume control ventilation during one lung ventilation in thoracic surgeries on the gas exchanges and the respiratory mechanical variables 2022-01-10 anticipated 60 Complete https://irct.ir/trial/60041 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is a randomized clinical trial in which patients are assigned to one of two study groups using simple randomization methods in order of their entry. The randomization unit is personal and using a lottery drawing method, the third person draws blindly a sealed paper on which one of two groups' name is written. Thus we could achieve a concealed random sequence for allocation of patients as the process of lottery is repeated for each new patient entered, Blinding description: Due to this fact that the study is performed under general anesthesia, the participating patients do not know the group and type of intervention. There is no possibility for blinding the person who intervenes and records the outcomes. 3 Thoracic surgery. Intervention 1: Intervention group: In the intervention group after induction of anesthesia and tracheal intubation with a left double lumen endotracheal tube, with the start of surgery, one-lung pressure control ventilation will begin for patients with the following characteristics: airway pressure = 20 cmH2O, respiratory rate = 12/min, to achieve the ideal tidal volume of 6 ml/kg gradual changes in airway pressure will be used. To achieve proper minute ventilation and maintain end-tidal carbon dioxide (ET-Co2) pressure in the range of 35-40 mmhg, the respiratory rate will be changed. For mechanical ventilation of patients the anesthesia machine model EDP-Neptune MEDEC made in Belgium is used. Intervention 2: Control group: In the control group, after induction of anesthesia, the patient was intubated with a left double lumen endotracheal tube. At the beginning of the surgery, one-lung volume control ventilation is started for patients with the following characteristics: tidal volume of 6 ml/kg and a respiratory rate of 12 per minute. A change in respiration rate will be used to achieve proper minute ventilation and maintain expiratory carbon dixide pressure in the range of 35-40 mmhg. For mechanical ventilation of patients, the anesthesia machine model EDP-Neptune MEDEC made in Belgium is used. 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 Mohammad Reza Ghodraty
Anesthesia Department, Firoozgar Hospital, Behafarin St. Karim Khan Av.
Tehran Iran (Islamic Republic of) 8874113911 +98 21 8894 6762 ghodrati.mr@iums.ac.ir Iran University of Medical Sciences scientific Mohammad Reza Ghodraty
Anesthesia Department, Firoozgar Hospital, Behafarin St. Karim Khan Av.
Tehran Iran (Islamic Republic of) 8874113911 +98 21 8894 6762 ghodrati.mr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients candidates for thoracic surgery under one-lung ventilation ASA physical class < or = class III Patients with a body mass index between 20 - 35 18 years 65 years Both Severe preoperative hypoxemia (SPo2 lower than 88% with room air) Patient dissatisfaction Treatment - Other Treatment - Other Intervention group: In the intervention group after induction of anesthesia and tracheal intubation with a left double lumen endotracheal tube, with the start of surgery, one-lung pressure control ventilation will begin for patients with the following characteristics: airway pressure = 20 cmH2O, respiratory rate = 12/min, to achieve the ideal tidal volume of 6 ml/kg gradual changes in airway pressure will be used. To achieve proper minute ventilation and maintain end-tidal carbon dioxide (ET-Co2) pressure in the range of 35-40 mmhg, the respiratory rate will be changed. For mechanical ventilation of patients the anesthesia machine model EDP-Neptune MEDEC made in Belgium is used. Control group: In the control group, after induction of anesthesia, the patient was intubated with a left double lumen endotracheal tube. At the beginning of the surgery, one-lung volume control ventilation is started for patients with the following characteristics: tidal volume of 6 ml/kg and a respiratory rate of 12 per minute. A change in respiration rate will be used to achieve proper minute ventilation and maintain expiratory carbon dixide pressure in the range of 35-40 mmhg. For mechanical ventilation of patients, the anesthesia machine model EDP-Neptune MEDEC made in Belgium is used. Arterial blood oxygen pressure (PaO2). Timepoint: Before starting one-lung ventilation and for second time, 30 min after start of one-lung ventilation. Method of measurement: Arterial blood gas analysis. Peak airway pressure. Timepoint: After tracheal intubation and then every 15 min during one-lung ventilation. Method of measurement: By airway pressure monitoring device included in anesthesia machine. End-tidal pressure of CO2. Timepoint: Every 15 min during surgery. Method of measurement: By Capnograph monitoring. Dynamic compliance of respiratory system. Timepoint: After tracheal intubation and then every 15 min during one-lung ventilation. Method of measurement: Using the standard formula and tidal volume divided in airway pressure. Respiratory dead space. Timepoint: After tracheal intubation and then 30 min after one-lung ventilation starting. Method of measurement: Calculation by the use of arterial and end tidal PCo2 pressure. Iran University of Medical Sciences Approved 2021-07-04 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)