NCT02992002

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

December 9, 2016

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Respiratory InsufficiencyShockEdema

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

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

Locations