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IRCT20121107011398N14 IRCT 2020-05-04 Iran University of Medical Sciences Comparison of two volume and pressure control ventilation modes during laparoscopic bariatric surgeries. The comparison of two volume and pressure control ventilation modes on the gas exchange and mechanical parameters of respiratory system during laparoscopic bariatric surgeries, a cross over clinical trial. 2019-03-20 anticipated 26 Complete https://irct.ir/trial/47306 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, 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' names 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 the fact that the general anesthesia study is performed, the participating patients do not know the group and type of intervention. There is no possibility of blinding the person who intervenes and records the outcomes. 3 Obesity. Intervention 1: The study protocol being a crossover, each participating patient will receive both types of interventions. The main intervention in the study is the pressure controlled mode of mechanical ventilation during bariatric surgery and its comparison with standard (volume controlled) ventilation. For this purpose, the participating patients were randomly divided into to groups: in the first group and after the induction of anesthesia, the patients were subjected to volume controlled mode and by 15 minutes after the commencement of the surgery, and intra-abdominal CO2 insufflation, the pressure controlled mode is applied. [volume control and then pressure control (VC-PC)]. For the pressure controlled mode, the ventilator is adjusted as follows: airway pressure 20 cmH2O, respiratory rate of 12 per minute. The airway pressure is progressively increased to reach the ideal tidal volume (6-8 cc/kg of ideal body weight). On the other hand, for the volume-controlled mode, the ventilator is adjusted on 7 cc/kg of ideal body weight. For both methods, the respiration rate module is used to keep the end tidal CO2 rate at 35-40 mmHg. Intervention 2: Control group: In second group the selection of ventilation mode is in opposite to the first group [Pressure control - Volume Control (PC-VC)]. The EDP-Neptune MEDEC BENELUX NV (BELGIUM) anesthesia machine and its ventilator were used for ventilation during anesthesia for both ventilation modes. No - There is not a plan to make this available Justification or reason for not sharing IPD is The personal information of the participants in the study is confidential and there is no need to publish it.
public Mohammad Reza Ghodraty
Anesthesia Department, Firoozgar hospital, Beh-afarin St. Karim Khan Ave.
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8894 6762 ghodrati.mr@iums.ac.ir Iran University of Medical Sciences scientific Elmira Sakhaeyan
Anesthesia Department, Firoozgar hospital, Beh-afarin St. Karim Khan Ave.
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8894 6762 elmirasakhaeyan@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Obese patients candidated for bariatric surgeries with body mass index (BMI) 40-55 Patients older than 18 and lower than 60 years ASA physical class < or = class III 18 years 60 years Both Patient dissatisfaction History of sever respiratory disease History of advanced cardiovascular disease E66 Overweight and obesity Treatment - Other Treatment - Other The study protocol being a crossover, each participating patient will receive both types of interventions. The main intervention in the study is the pressure controlled mode of mechanical ventilation during bariatric surgery and its comparison with standard (volume controlled) ventilation. For this purpose, the participating patients were randomly divided into to groups: in the first group and after the induction of anesthesia, the patients were subjected to volume controlled mode and by 15 minutes after the commencement of the surgery, and intra-abdominal CO2 insufflation, the pressure controlled mode is applied. [volume control and then pressure control (VC-PC)]. For the pressure controlled mode, the ventilator is adjusted as follows: airway pressure 20 cmH2O, respiratory rate of 12 per minute. The airway pressure is progressively increased to reach the ideal tidal volume (6-8 cc/kg of ideal body weight). On the other hand, for the volume-controlled mode, the ventilator is adjusted on 7 cc/kg of ideal body weight. For both methods, the respiration rate module is used to keep the end tidal CO2 rate at 35-40 mmHg. Control group: In second group the selection of ventilation mode is in opposite to the first group [Pressure control - Volume Control (PC-VC)]. The EDP-Neptune MEDEC BENELUX NV (BELGIUM) anesthesia machine and its ventilator were used for ventilation during anesthesia for both ventilation modes O2 saturation (SPo2). Timepoint: Every 5 min during surgery. Method of measurement: With Pulse Oximeter. End-tidal Co2. Timepoint: Every 5 min during surgery. Method of measurement: With Capnograph. Peak airway pressure. Timepoint: Every 5 min during surgery. Method of measurement: By the monitor of anesthesia machine. Arterial blood gas analysis. Timepoint: In 15 and 30 minutes after insufflation of gas into abdominal cavity. Method of measurement: By sending arterial blood sample to laboratory. Exhaled tidal volume. Timepoint: During Surgery. Method of measurement: By anesthesia machine. Dynamic pulmonary compliance. Timepoint: Every 5 min during surgery. Method of measurement: Calculation of variable by using the amounts of airway pressure and tidal volume. Respiratory dead space. Timepoint: Every 5 min during surgery. Method of measurement: Calculation by the use of arterial and end tidal PCo2 pressure. Iran University of Medical Sciences Approved 2019-06-22 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)