Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, 10430, Indonesia
NCT Number: NCT02834039
This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and tidal volume 10ml/kgBW in laparoscopic nephrectomy patients
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Jakarta, DKI Jakarta, 10430, Indonesia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drop out criteria:
Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.
Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.
Time frame: 2 months
Evaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor.
Time frame: 2 months
Global End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.
Time frame: 2 months
Regional End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.
Time frame: 2 months
Tidal Impedance Variation value divided by atmospheric pressure above PEEP value.
Indonesia University
Other
Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW in Laparoscopic Nephrectomy Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07527637
Endocrine System Diseases, Female Urogenital Diseases
View Trial DetailsNCT07433530
Laparoscopic Nephrectomy
Gaziantep, Sehitkamil, Turkey (Türkiye)
View Trial DetailsNCT07078123
Endocrine System Diseases, Genital Diseases
View Trial DetailsNCT04863716
Erector Spinae Plane Block, Laparoscopic Nephrectomy
Istanbul, Zeytinburnu, Turkey (Türkiye)
View Trial Details