PneumothoraxNCT02232841
Electrical Impedance Imaging of Patients on Mechanical Ventilation
An observational study of Pneumothorax and Pulmonary Contusion, run by Colorado State University at 1 site in United States.
Trial summary
The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are mechanically ventilated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Pulmonary Contusion, Pleural Effusion
- What is being tested?
- Mechanical Ventilation and CT Scan
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2016
- 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: Mechanically ventilated adult intensive care unit patients at Medical Center of the Rockies with pulmonary pathology who have received or will be receiving a CT scan as part of their standard care
Who may be able to join
- Patients admitted to the ICU at Medical Center of the Rockies and on mechanical ventilation
- Age greater than or equal to 18
- Computed Tomography of the chest during normal course of hospital admission
Who cannot join
- Age <18
- Any skin disorder that would prevent placement of the electrodes on the chest wall
- Hemodynamic instability prohibiting patient from being moved to place the device
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
Official title: Pilot Study: Electrical Impedance Imaging of Patients on Mechanical Ventilation With Lung Pathology
The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are mechanically ventilated. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.
Read the detailed description
The goal of this study is to characterize the ability of the electrical impedance tomography system (hardware and software) to distinguish between lung pathologies by assessing the sensitivity and specificity as well as the overall agreement with the CT scan in terms of spatial resolution. The study will test, as well as refine, the mathematical algorithms needed to create meaningful outputs on adult patients receiving mechanical ventilation and who also have received or will be receiving a CT scan as part of their standard of care.
- Conditions
- Pneumothorax, Pulmonary Contusion, Pleural Effusion, Pulmonary Edema, Atelectasis, Hyperinflation
- Being tested
- Mechanical Ventilation, CT Scan
- Keywords
- Electrical impedance tomography, lung imaging
- Medical subject headings
- Pneumothorax, Pleural Effusion, Pulmonary Edema, Pulmonary Atelectasis, Emphysema, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical VentilationDevice
Subjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria
CT ScanDevice
Subjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilation | Hospitalized adult patients with lung injury receiving mechanical ventilation and who also have received or will receive a CT scan as part of their standard care Receives: Device: Mechanical Ventilation; Device: CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for diagnosing lung pathology
The sensitivity and specificity of EIT for the detection and identification of different types of lung pathology will be assessed with clinical diagnosis aided by CT scan as the gold standard.
Measured: One year
Secondary outcomes (1)
Regional correlation with CT scan
The spatial correlation between the organs and lung pathology in the CT scan image in the plane of the electrodes and the EIT image will be computed.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Jennifer L Mueller, Ph.D., Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232841
- Sponsor's protocol ID
- 13-4656H
- Other IDs
- 1R21EB016869-01A1
- Status last verified
- Jul 2016
- First submitted
- 10 Jun 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamilton SJ, Mueller JL. Direct EIT reconstructions of complex admittivities on a chest-shaped domain in 2-D. IEEE Trans Med Imaging. 2013 Apr;32(4):757-69. doi: 10.1109/TMI.2012.2237389. Epub 2013 Jan 9.
PubMed 23314771
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Electrical Impedance Imaging of Patients on Mechanical Ventilation With Lung Pathology
- ClinicalTrials.gov ID
- NCT02232841
- Acronym / sponsor ID
- 13-4656H
- Conditions
- Pneumothorax, Pulmonary Contusion, Pleural Effusion, Pulmonary Edema, Atelectasis, Hyperinflation
- Keywords
- Electrical impedance tomography, lung imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Sep 2014 (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 goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are mechanically ventilated. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.
Detailed description
The goal of this study is to characterize the ability of the electrical impedance tomography system (hardware and software) to distinguish between lung pathologies by assessing the sensitivity and specificity as well as the overall agreement with the CT scan in terms of spatial resolution. The study will test, as well as refine, the mathematical algorithms needed to create meaningful outputs on adult patients receiving mechanical ventilation and who also have received or will be receiving a CT scan as part of their standard of care.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilation | – | Device: Mechanical Ventilation, Device: CT ScanHospitalized adult patients with lung injury receiving mechanical ventilation and who also have received or will receive a CT scan as part of their standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated adult intensive care unit patients at Medical Center of the Rockies with pulmonary pathology who have received or will be receiving a CT scan as part of their standard care
Key inclusion criteria (3 listed)
- Patients admitted to the ICU at Medical Center of the Rockies and on mechanical ventilation
- Age greater than or equal to 18
- Computed Tomography of the chest during normal course of hospital admission
Key exclusion criteria (3 listed)
- Age <18
- Any skin disorder that would prevent placement of the electrodes on the chest wall
- Hemodynamic instability prohibiting patient from being moved to place the device
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 |
|---|---|---|
| Mechanical VentilationSubjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria | Device | Mechanical ventilation |
| CT ScanSubjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria | Device | Mechanical ventilation |
Primary outcome
Sensitivity and specificity for diagnosing lung pathology
Time frame: One year
The sensitivity and specificity of EIT for the detection and identification of different types of lung pathology will be assessed with clinical diagnosis aided by CT scan as the gold standard.
1 secondary outcome
Regional correlation with CT scan
Time frame: One year
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 1 Feb 2017.
- Background: PubMed 23314771Hamilton SJ, Mueller JL. Direct EIT reconstructions of complex admittivities on a chest-shaped domain in 2-D. IEEE Trans Med Imaging. 2013 Apr;32(4):757-69. doi: 10.1109/TMI.2012.2237389. Epub 2013 Jan 9.
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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.
Jennifer L Mueller, Ph.D. principal investigator
Colorado State University
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 Pneumothorax and Pulmonary Contusion, run by Colorado State University at 1 site in United States.
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 3 inclusion and 3 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 1 Feb 2017. 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 United States. 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?
Sensitivity and specificity for diagnosing lung pathology (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232841, which also lists 1 linked publication.
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 1 Feb 2017.