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

August 15, 2017 updated by: Dita Aditianingsih, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal impedance variation regional (TIV-ROI)
Time Frame: 2 months
Evaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor.
2 months
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.
2 months
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.
2 months
Compliance regional (CR)
Time Frame: 2 months
Tidal Impedance Variation value divided by atmospheric pressure above PEEP value.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Dita Aditianingsih, Consultant, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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