Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW
- Conditions
- Laparoscopic Nephrectomy
- Interventions
- Procedure: Tidal volume 10 ml/kgBWProcedure: Tidal volume 6 ml/kgBW
- Registration Number
- NCT02834039
- Lead Sponsor
- Indonesia University
- Brief Summary
This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and tidal volume 10ml/kgBW in laparoscopic nephrectomy patients
- Detailed Description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, electrocardiogram (ECG) and pulse-oximeter was set on the subjects in the operation room. Anesthesia procedure was epidural regional block. After given premedication (midazolam 0.05 mg/kgBW and fentanyl 1-2 ug/kgBW), induced with propofol, 1-2 mg/kgbb, endotracheal tube intubation was done facilitated by atracurium 0.5 mg/kgbb. Mechanical ventilation was set up with volume control mode, (Positive End Expiratory Pressure) PEEP 5cmH2O (5 centimeters of water), O2 fraction (FiO2) 30-50%, target carbondioxide (CO2) 35-45%. Volume tidal was given according to the group (6 mL/kgBW or 10 ml/kgBW). Hemodynamic, ventilation parameter, Electrical Impedance Tomography (EIT) parameter were recorded. If desaturation happened intraoperatively will be managed by increasing FiO2 and recruitment maneuver until oxygen saturation (SpO2) \>95%. Data was analyzed using Statistical Program for Social Sciences (SPSS), for numeric data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square or Fisher Exact Test. Significant value is p\<0.05.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Subjects aged 18-60 years old
- Subjects with good health condition (did not suffer from cancer, diabetes mellitus, kidney diseases, cardiovascular diseases, liver diseases, hematologic disorders, HIV, hepatitis)
- Subjects had the same blood type with the renal recipients and had passed cross match test
- Subjects were willing to be renal donors.
- Subjects with pulmonary diseases or PaO2 (arterial partial pressure of oxygen) /FiO2 < 300 mmHg
- Subjects with Body Mass Index (BMI) > 30 kg/m2
- Subjects who had mechanical ventilation 2 weeks prior to the surgery
- Subjects with congestive heart failure
- Subjects with neuromuscular diseases.
Drop out criteria:
- Subjects with intraoperative pulmonary complications not due to ventilation
- Subjects with intraoperative cardiac arrest
- Subjects with desaturation that could not be managed by FiO2 increase, PEEP or recruitment maneuver, and required tidal volume changes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tidal volume 10 ml/kgBW Tidal volume 10 ml/kgBW Tidal volume 10 ml/kgBW was given to patients after endotracheal tube was inserted properly. Tidal volume 6 ml/kgBW Tidal volume 6 ml/kgBW Tidal volume 6 ml/kgBW was given to patients after endotracheal tube was inserted properly
- Primary Outcome Measures
Name Time Method Tidal impedance variation regional (TIV-ROI) 2 months Evaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor.
Global End expiratory lung impedance difference (ΔEELI-g) 2 months Global End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.
Regional End expiratory lung impedance difference (ΔEELI- ROI) 2 months Regional End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.
Compliance regional (CR) 2 months Tidal Impedance Variation value divided by atmospheric pressure above PEEP value.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cipto Mangunkusumo Central National Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia