Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography

May 2, 2018 updated by: Tobias Becher, University Hospital Schleswig-Holstein
The study investigates the influence of a clinically indicated fluid challenge on end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data will be collected before, during and after infusion of 500 ml of crystalloid solution in mechanically ventilated patients on an operative intensive care unit.

Study Overview

Study Type

Observational

Enrollment (Actual)

25

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

    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24145
        • University Medical Center Schleswig Holstein, Campus Kiel

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mixed population of intensive care unit patients

Description

Inclusion Criteria:

  • patients on mechanical ventilation
  • clincial decision to monitor regional ventilation with electrical impedance tomography
  • clinical indication for fluid challenge
  • established cardiac output monitoring with transpulmonary thermodilution

Exclusion Criteria:

  • age < 18 years
  • open lung injuries
  • instable injury of spine or cranium
  • thoracic metal implants
  • body mass index > 35

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in end-expiratory lung impedance (EELI)
Time Frame: 15-30 minutes
To assess the effect of fluid challenge on EELI, the change in EELI during the fluid challenge will be measured by electrical impedance tomography and will be compared to the change in EELI during the last 15 minutes before start of the fluid challenge.
15-30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between change in end-expiratory lung impedance and change in intrathoracic blood volume
Time Frame: 15-30 minutes
We will assess the correlation between the change in end-expiratory lung impedance during infusion of 500 ml of crystalloid solution and the change in intrathoracic blood volume (assessed by transpulmonary thermodilution) during the same time period.
15-30 minutes
Fluid responsiveness
Time Frame: 15-30 minutes
We will investigate whether the ratio of cardiac-related impedance changes to ventilation-related impedance changes, measured by EIT at baseline (i.e. before start of fluid challenge), can predict fluid responsiveness, defined as an increase in stroke volume of greater or equal to 15% compared to baseline.
15-30 minutes

Collaborators and Investigators

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

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 (Actual)

December 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimate)

December 14, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • EIT Fluid Challenge

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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