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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02992002
Other study ID # EIT Fluid Challenge
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2016
Est. completion date December 2017

Study information

Verified date May 2018
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Fluid Challenge
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.

Locations

Country Name City State
Germany University Medical Center Schleswig Holstein, Campus Kiel Kiel Schleswig-Holstein

Sponsors (1)

Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in end-expiratory lung impedance (EELI) 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 Correlation between change in end-expiratory lung impedance and change in intrathoracic blood volume 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
Secondary Fluid responsiveness 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
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