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Completed

NCT Number: NCT02834039

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tidal volume 6 ml/kgBW

Procedure

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

Tidal volume 10 ml/kgBW

Procedure

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

Primary outcomes

  1. Tidal impedance variation regional (TIV-ROI)

    Time frame: 2 months

    Evaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor.

  2. Global End expiratory lung impedance difference (ΔEELI-g)

    Time frame: 2 months

    Global End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.

  3. Regional End expiratory lung impedance difference (ΔEELI- ROI)

    Time frame: 2 months

    Regional End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.

  4. Compliance regional (CR)

    Time frame: 2 months

    Tidal Impedance Variation value divided by atmospheric pressure above PEEP value.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2016
Registry last updated
Aug 18, 2017

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.

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