Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography
1 other identifier
observational
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 3, 2018
May 1, 2018
1 year
December 9, 2016
May 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Correlation between change in end-expiratory lung impedance and change in intrathoracic blood volume
15-30 minutes
Fluid responsiveness
15-30 minutes
Interventions
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.
Eligibility Criteria
Mixed population of intensive care unit patients
You may qualify if:
- 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
You may not qualify if:
- age \< 18 years
- open lung injuries
- instable injury of spine or cranium
- thoracic metal implants
- body mass index \> 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Schleswig Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24145, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Tobias Becher
Study Record Dates
First Submitted
December 9, 2016
First Posted
December 14, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 3, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share