Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW

Study Overview
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Brief Summary
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This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and tidal volume 10ml/kgBW in laparoscopic nephrectomy patients

Detailed Description
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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.

Official Title
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Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW in Laparoscopic Nephrectomy Patients

Conditions
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Laparoscopic Nephrectomy

Intervention / Treatment
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* Procedure: Tidal volume 6 ml/kgBW
* Procedure: Tidal volume 10 ml/kgBW


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tidal volume 6 ml/kgBW<br>Tidal volume 6 ml/kgBW was given to patients after endotracheal tube was inserted properly | Procedure: Tidal volume 6 ml/kgBW<br>* Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.<br>|
| Active Comparator: Tidal volume 10 ml/kgBW<br>Tidal volume 10 ml/kgBW was given to patients after endotracheal tube was inserted properly. | Procedure: Tidal volume 10 ml/kgBW<br>* Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tidal impedance variation regional (TIV-ROI) | Evaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor. | 2 months | 
| Global End expiratory lung impedance difference (ΔEELI-g) | Global End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor. | 2 months | 
| Regional End expiratory lung impedance difference (ΔEELI- ROI) | Regional End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor. | 2 months | 
| Compliance regional (CR) | Tidal Impedance Variation value divided by atmospheric pressure above PEEP value. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tidal volume, renal transplant, donor, nephrectomy, ventilation, Living renal transplant donor patient