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Completed

NCT Number: NCT02992002

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

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.

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Key information

Conditions

Respiratory Failure Circulatory Failure Edema Fluid Overload Fluid Responsiveness Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Shock Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Schleswig Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24145, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Fluid challenge

Other

Infusion of a standardized amount of crystalloid solution (500 ml) to assess fluid responsiveness by means of changes in cardiac output, assessed by transpulmonary thermodilution.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 14, 2016
Registry last updated
May 3, 2018

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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