Respiratory FailureNCT02992002
Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography
An observational study of Respiratory Failure and Circulatory Failure, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Circulatory Failure, Fluid Responsiveness
- What is being tested?
- Fluid Challenge
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mixed population of intensive care unit patients
Who may be able to join
- 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
Who cannot join
- age < 18 years
- open lung injuries
- instable injury of spine or cranium
- thoracic metal implants
- body mass index > 35
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Schleswig Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24145
About this study
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.
- Being tested
- Fluid Challenge
- Medical subject headings
- Respiratory Insufficiency, Shock, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid ChallengeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15-30 minutes
Secondary outcomes (2)
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.
Measured: 15-30 minutes
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.
Measured: 15-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Becher, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992002
- Sponsor's protocol ID
- EIT Fluid Challenge
- Status last verified
- May 2018
- First submitted
- 9 Dec 2016
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT02992002
- Acronym / sponsor ID
- EIT Fluid Challenge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mixed population of intensive care unit patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- age < 18 years
- open lung injuries
- instable injury of spine or cranium
- thoracic metal implants
- body mass index > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid ChallengeInfusion of a standardized amount of crystalloid solution (500 ml) to assess fluid responsiveness by means of changes in cardiac output, assessed by transpulmonary thermodilution. | Other | – |
Primary outcome
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.
2 secondary outcomes
Correlation between change in end-expiratory lung impedance and change in intrathoracic blood volume
Time frame: 15-30 minutes
Fluid responsiveness
Time frame: 15-30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Circulatory Failure, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in end-expiratory lung impedance (EELI) (time frame: 15-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.