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

University of Indonesia (UI)

Status

Completed

Conditions

Laparoscopic Nephrectomy

Treatments

Procedure: Tidal volume 10 ml/kgBW

Procedure: Tidal volume 6 ml/kgBW

Study type

Interventional

Funder types

Other

Identifiers

NCT02834039

IndonesiaUAnes004

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.