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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02834039
Enrollment
30
Registered
2016-07-15
Start date
2016-05-31
Completion date
2017-03-31
Last updated
2017-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Nephrectomy

Keywords

Tidal volume, renal transplant, donor, nephrectomy, ventilation, Living renal transplant donor patient

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.

Interventions

PROCEDURETidal volume 6 ml/kgBW

Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.

PROCEDURETidal volume 10 ml/kgBW

Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Regional End expiratory lung impedance difference (ΔEELI- ROI)2 monthsRegional End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.
Tidal impedance variation regional (TIV-ROI)2 monthsEvaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor.
Global End expiratory lung impedance difference (ΔEELI-g)2 monthsGlobal End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.
Compliance regional (CR)2 monthsTidal Impedance Variation value divided by atmospheric pressure above PEEP value.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026