Respiratory MonitoringPhase 3NCT02773680
Human Electrical-Impedance-Tomography Reconstruction Models
A Phase 3 study testing "electrical impedance tomography" in people with Respiratory Monitoring, run by Medical University of Vienna.
Trial summary
Current EIT analyses are based on the assumption of a circular thorax-shape and do not provide any information on lung borders. The aim is to obtain the body and lung border contours of male subjects by multi-detector computed tomography (MDCT) in defined thresholds of anthropometric data (gender = male; height… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Monitoring
- What is being tested?
- "electrical impedance tomography"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2017
- Phase
- Phase 3
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- spontaneous breathing male subjects
- age > 18,
- clinical indication for thoracic CT scanning,
- matching of weight and height to the predefined model-thresholds
Who cannot join
- pre-existing chronic pulmonary disease
- skin lesions / wounds in the thoracic plane where the EIT SensorBelt will be attached
- known allergy against any ingredient of the used ContactAgent
- abnormalities in thoracic shape as defined by the radiologist in charge (e.g. extreme kyphosis, funnel chest, pigeon breast, multiple rip fractures)
- pneumothorax
- pace maker (external and internal)
- other implanted electrical devices
- other methods measuring bioimpedance
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of CT-derived Thoracic Electrical-Impedance-Tomography Finite Element Models
Current EIT analyses are based on the assumption of a circular thorax-shape and do not provide any information on lung borders. The aim is to obtain the body and lung border contours of male subjects by multi-detector computed tomography (MDCT) in defined thresholds of anthropometric data (gender = male; height; weight) for calibration of more realistic EIT reconstruction models.
Read the detailed description
A major drawback of EIT is its relatively poor spatial resolution and its limitation in measuring changes in bioimpedance as compared to a reference state (and not absolute quantities). Therefore, the technique cannot differentiate between extrapulmonary structures (muscles, thorax, heart, large vessels, spine, etc.) and non-aerated lung tissues - which is a major limitation for the clinical use of information derived from EIT-imaging. Moreover, current EIT-reconstruction algorithms are based on the consideration of a complete circular thoracic shape and do not take into account the body contours and lung borders.
The investigators are convinced that EIT-derived dynamic bedside lung imaging can be advanced by morphing computed tomography (CT) scans of the respective thoracic levels with concomitant EIT images - thus enhancing EIT-image information with CT-data. Integrating the anatomy of thoracic shape and lung borders provided by high-spatial resolution multi detector CT-scans (MDCT) with high-temporal resolution EIT has the potential to improve image quality considerably. This data can be used to compute mean EIT-reconstruction models that further offer the possibility to develop novel and clinically meaningful EIT parameters.
Therefore, the investigators hypothesize that by integration of CT-scan information of body and lung contours (and by computing different EIT reconstruction models) the current methodological limitations of EIT technology can be overcome.
- Conditions
- Respiratory Monitoring
- Being tested
- "electrical impedance tomography"
- Keywords
- respiration, monitoring, physiologic, diagnostic techniques, respiratory system
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"electrical impedance tomography"Device
One continous electrical impedance tomography (EIT) measurement per subject of approximately 5 minutes duration (2 min prior to MDCT scanning, during end-inspiratory MDCT acquisition and 2 min after MDCT scanning)
| Study group | Role | What they receive |
|---|---|---|
| Study cohort 1 | Experimental | "electrical impedance tomography" Receives: Device: "electrical impedance tomography" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical Impedance Tomography Finite Element Model
Based on CT-derived thorax, lung and heart contours we propose to calculate human finite element models (FEM) for EIT analysis
Measured: approximately 1 year through study completion
Secondary outcomes (3)
height
Measured: at the time-point of inclusion
weight
Measured: at the time-point of inclusion
gender
Measured: at the time-point of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MonitoringStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna
- Investigators
- Stefan Boehme, MD, Principal investigator, Department of General Anesthesia, Intensive Care Medicine and Pain Management, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773680
- Sponsor's protocol ID
- 1917/2015
- Status last verified
- May 2016
- First submitted
- 9 May 2016
- Last updated
- 16 May 2016
- 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 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of CT-derived Thoracic Electrical-Impedance-Tomography Finite Element Models
- ClinicalTrials.gov ID
- NCT02773680
- Acronym / sponsor ID
- 1917/2015
- Conditions
- Respiratory Monitoring
- Keywords
- respiration, monitoring, physiologic, diagnostic techniques, respiratory system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 16 May 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.
Current EIT analyses are based on the assumption of a circular thorax-shape and do not provide any information on lung borders. The aim is to obtain the body and lung border contours of male subjects by multi-detector computed tomography (MDCT) in defined thresholds of anthropometric data (gender = male; height; weight) for calibration of more realistic EIT reconstruction models.
Detailed description
A major drawback of EIT is its relatively poor spatial resolution and its limitation in measuring changes in bioimpedance as compared to a reference state (and not absolute quantities). Therefore, the technique cannot differentiate between extrapulmonary structures (muscles, thorax, heart, large vessels, spine, etc.) and non-aerated lung tissues - which is a major limitation for the clinical use of information derived from EIT-imaging. Moreover, current EIT-reconstruction algorithms are based on the consideration of a complete circular thoracic shape and do not take into account the body contours and lung borders.
The investigators are convinced that EIT-derived dynamic bedside lung imaging can be advanced by morphing computed tomography (CT) scans of the respective thoracic levels with concomitant EIT images - thus enhancing EIT-image information with CT-data. Integrating the anatomy of thoracic shape and lung borders provided by high-spatial resolution multi detector CT-scans (MDCT) with high-temporal resolution EIT has the potential to improve image quality considerably. This data can be used to compute mean EIT-reconstruction models that further offer the possibility to develop novel and clinically meaningful EIT parameters.
Therefore, the investigators hypothesize that by integration of CT-scan information of body and lung contours (and by computing different EIT reconstruction models) the current methodological limitations of EIT technology can be overcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort 1 | Experimental | Device: "electrical impedance tomography""electrical impedance tomography" |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- spontaneous breathing male subjects
- age > 18,
- clinical indication for thoracic CT scanning,
- matching of weight and height to the predefined model-thresholds
Key exclusion criteria (8 listed)
- pre-existing chronic pulmonary disease
- skin lesions / wounds in the thoracic plane where the EIT SensorBelt will be attached
- known allergy against any ingredient of the used ContactAgent
- abnormalities in thoracic shape as defined by the radiologist in charge (e.g. extreme kyphosis, funnel chest, pigeon breast, multiple rip fractures)
- pneumothorax
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 |
|---|---|---|
| "electrical impedance tomography"One continous electrical impedance tomography (EIT) measurement per subject of approximately 5 minutes duration (2 min prior to MDCT scanning, during end-inspiratory MDCT acquisition and 2 min after MDCT scanning) | Device | Study cohort 1 |
Primary outcome
Electrical Impedance Tomography Finite Element Model
Time frame: approximately 1 year through study completion
Based on CT-derived thorax, lung and heart contours we propose to calculate human finite element models (FEM) for EIT analysis
3 secondary outcomes
height
Time frame: at the time-point of inclusion
weight
Time frame: at the time-point of inclusion
gender
Time frame: at the time-point of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- 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.
Stefan Boehme, MD principal investigator
Department of General Anesthesia, Intensive Care Medicine and Pain Management, Medical University of Vienna, Austria
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing "electrical impedance tomography" in people with Respiratory Monitoring, run by Medical University of Vienna.
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 8 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: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Boehme, MD (+43 40400 41020, stefan.boehme@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical Impedance Tomography Finite Element Model (time frame: approximately 1 year through study completion). 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 16 May 2016.