Clinical Trials Directory

Trials / Completed

CompletedNCT02834039

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETidal volume 6 ml/kgBWTidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.
PROCEDURETidal volume 10 ml/kgBWTidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.

Timeline

Start date
2016-05-01
Primary completion
2017-02-28
Completion
2017-03-31
First posted
2016-07-15
Last updated
2017-08-18

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT02834039. Inclusion in this directory is not an endorsement.