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

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ClinicalTrials.gov Identifier: NCT02834039
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Dita Aditianingsih, Indonesia University

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

Condition or disease Intervention/treatment Phase
Laparoscopic Nephrectomy Procedure: Tidal volume 6 ml/kgBW Procedure: Tidal volume 10 ml/kgBW Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW in Laparoscopic Nephrectomy Patients
Study Start Date : May 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : March 31, 2017

Arm Intervention/treatment
Active Comparator: Tidal volume 6 ml/kgBW
Tidal volume 6 ml/kgBW was given to patients after endotracheal tube was inserted properly
Procedure: Tidal volume 6 ml/kgBW
Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.

Active Comparator: Tidal volume 10 ml/kgBW
Tidal volume 10 ml/kgBW was given to patients after endotracheal tube was inserted properly.
Procedure: Tidal volume 10 ml/kgBW
Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834039


Locations
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Indonesia
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Dita Aditianingsih, Consultant Indonesia University

Publications:

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Responsible Party: Dita Aditianingsih, Consultant, Anesthesiologist, Indonesia University
ClinicalTrials.gov Identifier: NCT02834039     History of Changes
Other Study ID Numbers: IndonesiaUAnes004
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dita Aditianingsih, Indonesia University:
Tidal volume
renal transplant
donor
nephrectomy
ventilation
Living renal transplant donor patient