Clinical trial NCT02834039: Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW
Official title: Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW in Laparoscopic Nephrectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Nephrectomy
Keywords: Tidal volume
renal transplant
donor
nephrectomy
ventilation
Living renal transplant donor patient
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tidal impedance variation regional (TIV-ROI)
timeFrame: 2 months
measure: Global End expiratory lung impedance difference (ΔEELI-g)
timeFrame: 2 months
measure: Regional End expiratory lung impedance difference (ΔEELI- ROI)
timeFrame: 2 months
measure: Compliance regional (CR)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Dita Aditianingsih, Consultant
role: PRINCIPAL_INVESTIGATOR
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