Electric Impedance TomographyBroncho-EITNCT01294813
Bronchoscopy and Electric Impedance Tomography (EIT) Pilot Study
A study testing Electrical Impedance Tomography (EIT) in people with Electric Impedance Tomography and Bronchoscopy, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Electrical Impedance Tomography (EIT)is a technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a radiation free, non-invasive and portable lung imaging technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electric Impedance Tomography, Bronchoscopy, Change in Lung Impedance Due to Ventilation
- What is being tested?
- Electrical Impedance Tomography (EIT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Apr 2011
- Phase
- Interventional
- 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
Who may be able to join
- Female and male patients > 18 years old
- Mechanically ventilated patients who routinely undergo bronchoscopy
Who cannot join
- Pregnancy and Breastfeeding
- Active implants, heart pace makers and implanted converter defibrillator
- Foreign metallic objects in the thorax
- Cardiac valves
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Faculty Medical Clinic 1, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
Stefan Krueger, MD, Assistant Professor, ++49 241 80 80202 ext. 80202, stkrueger@ukaachen.de
Sigrid Gloeggler, M.Sc., ++49 241 8035226 ext. 35226, sgloeggler@ukaachen.de
About this study
Official title: Bronchoscopy and Electric Impedance Tomography to Investigate the Influence of Bronchoscopy on Pulmonary Regional Ventilation Measurements by Electric Impedance Tomography (EIT)
Electrical Impedance Tomography (EIT)is a technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a radiation free, non-invasive and portable lung imaging technique. Impedance changes in lung ventilation are investigated in mechanically ventilated patients who routinely undergo bronchoscopy in intensive care medicine. Bronchoscopy is performed to suction secretions as well as to analyze the secretions to recognize inflammations and diseases. It is an essential intervention which causes changes in ventilation which remain for 1-2 hours. It is not completely investigated why these changes in ventilation remain for so long time and how they are distributed regionally. Therefore the purpose of this study is to investigate the change in pulmonary regional ventilation in patients who routinely undergo bronchoscopy to possibly generate ideas how to optimize the ventilation after bronchoscopy to optimize the patient´s treatment.
Read the detailed description
In 20 mechanically ventilated patients who routinely undergo bronchoscopy Electrical Impedance Tomography (EIT) measurements whereby, evaluable data of 10 patients are needed, of about 1-2 minutes are performed directly before, directly after and 10, 30, and 60 minutes after bronchoscopy parallel to the following routine measurements: tidal volume, resistance, compliance, heart rate, blood pressure, SpO2 and blood gas values. Prior to the examination a rubber belt with 16 integrated electrocardiographic electrodes is placed around the thorax connected with an EIT- device. EIT data are generated by application of a small alternating current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. The EIT provides a mapping of the distribution of the lung´s electrical impedance and exhibits a far temporal resolution of up to 40 tomograms per second. Because of electrical impedance of the pulmonal tissue is dependant to the air content, the air distribution within the lung over a certain period can be monitored. Analyzing the EIT- data it might be possible to explain the distribution in regional ventilation and how the ventilation could be optimized right after the bronchoscopy to optimize the patient´s treatment.
- Conditions
- Electric Impedance Tomography, Bronchoscopy, Change in Lung Impedance Due to Ventilation, Recruitment, Improvement the Treatment of the Patient
- Being tested
- Electrical Impedance Tomography (EIT)
- Keywords
- Electric Impedance Tomography (EIT), Ventilation, Bronchoscopy, Lung Impedance, Recruitment
- 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 (EIT)Device
EIT measurements of 1-2 minutes are performed in patients who routinely undergo bronchoscopy (during 1.5 hours) before, directly after and 10, 30, 60 minutes after bronchoscopy. Therefore the rubber belt including 16 integrated electrographic electrodes is placed around the patient´s chest and connected with an EIT device. EIT data are generated by application of a small alternating current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. Pseudonomyzed EIT data are evaluated descriptively.
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopy-EIT | Experimental | Patients who routinely undergo bronchoscopy will be measured by EIT directly before, directly after and 10, 30, 60 minutes after bronchoscopy with a rubber belt which is placed around their chest. The EIT measurements will take 1-2 minutes; the total examination will last 1.5 hours. Receives: Device: Electrical Impedance Tomography (EIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the change in lung impedance due to ventilation before and after bronchoscopy by EIT measurements
It will be investigated if there are changes in lung impedance due to changes in ventilation before, directly after and 10, 30, 60 minutes after bronchoscopy in order to investigate their regional distribution and to generate ideas how the ventilation could be optimized to improve recruitment of the patient´s treatment
Measured: Single Measurement of 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electric Impedance TomographyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Krueger, MD, Assoc. Prof., Principal investigator, University Hospital Aachen, Medical Clinic 1, Section of Pneumology, 52074 Aachen, Nordrhein-Westfalen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294813
- Sponsor's protocol ID
- Bronchoscopy- EIT
- Acronym
- Broncho-EIT
- Status last verified
- Feb 2011
- First submitted
- 10 Feb 2011
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopy and Electric Impedance Tomography to Investigate the Influence of Bronchoscopy on Pulmonary Regional Ventilation Measurements by Electric Impedance Tomography (EIT)
- ClinicalTrials.gov ID
- NCT01294813
- Acronym / sponsor ID
- Broncho-EIT / Bronchoscopy- EIT
- Conditions
- Electric Impedance Tomography, Bronchoscopy, Change in Lung Impedance Due to Ventilation, Recruitment, Improvement the Treatment of the Patient
- Keywords
- Electric Impedance Tomography (EIT), Ventilation, Bronchoscopy, Lung Impedance, Recruitment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 14 Feb 2011 (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.
Electrical Impedance Tomography (EIT)is a technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a radiation free, non-invasive and portable lung imaging technique. Impedance changes in lung ventilation are investigated in mechanically ventilated patients who routinely undergo bronchoscopy in intensive care medicine. Bronchoscopy is performed to suction secretions as well as to analyze the secretions to recognize inflammations and diseases. It is an essential intervention which causes changes in ventilation which remain for 1-2 hours. It is not completely investigated why these changes in ventilation remain for so long time and how they are distributed regionally. Therefore the purpose of this study is to investigate the change in pulmonary regional ventilation in patients who routinely undergo bronchoscopy to possibly generate ideas how to optimize the ventilation after bronchoscopy to optimize the patient´s treatment.
Detailed description
In 20 mechanically ventilated patients who routinely undergo bronchoscopy Electrical Impedance Tomography (EIT) measurements whereby, evaluable data of 10 patients are needed, of about 1-2 minutes are performed directly before, directly after and 10, 30, and 60 minutes after bronchoscopy parallel to the following routine measurements: tidal volume, resistance, compliance, heart rate, blood pressure, SpO2 and blood gas values. Prior to the examination a rubber belt with 16 integrated electrocardiographic electrodes is placed around the thorax connected with an EIT- device. EIT data are generated by application of a small alternating current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. The EIT provides a mapping of the distribution of the lung´s electrical impedance and exhibits a far temporal resolution of up to 40 tomograms per second. Because of electrical impedance of the pulmonal tissue is dependant to the air content, the air distribution within the lung over a certain period can be monitored. Analyzing the EIT- data it might be possible to explain the distribution in regional ventilation and how the ventilation could be optimized right after the bronchoscopy to optimize the patient´s treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy-EIT | Experimental | Device: Electrical Impedance Tomography (EIT)Patients who routinely undergo bronchoscopy will be measured by EIT directly before, directly after and 10, 30, 60 minutes after bronchoscopy with a rubber belt which is placed around their chest. The EIT measurements will take 1-2 minutes; the total examination will last 1.5 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female and male patients > 18 years old
- Mechanically ventilated patients who routinely undergo bronchoscopy
Key exclusion criteria (4 listed)
- Pregnancy and Breastfeeding
- Active implants, heart pace makers and implanted converter defibrillator
- Foreign metallic objects in the thorax
- Cardiac valves
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 (EIT)EIT measurements of 1-2 minutes are performed in patients who routinely undergo bronchoscopy (during 1.5 hours) before, directly after and 10, 30, 60 minutes after bronchoscopy. Therefore the rubber belt including 16 integrated electrographic electrodes is placed around the patient´s chest and connected with an EIT device. EIT data are generated by application of a small alternating current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. Pseudonomyzed EIT data are evaluated descriptively. | Device | Bronchoscopy-EIT |
Primary outcome
Comparison of the change in lung impedance due to ventilation before and after bronchoscopy by EIT measurements
Time frame: Single Measurement of 1.5 hours
It will be investigated if there are changes in lung impedance due to changes in ventilation before, directly after and 10, 30, 60 minutes after bronchoscopy in order to investigate their regional distribution and to generate ideas how the ventilation could be optimized to improve recruitment of the patient´s treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
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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 Krueger, MD, Assoc. Prof. principal investigator
University Hospital Aachen, Medical Clinic 1, Section of Pneumology, 52074 Aachen, Nordrhein-Westfalen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography (EIT) in people with Electric Impedance Tomography and Bronchoscopy, run by RWTH Aachen University 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 2 inclusion and 4 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 Feb 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Krueger, MD (0049 241 8080202 ext. 80202, stkrueger@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the change in lung impedance due to ventilation before and after bronchoscopy by EIT measurements (time frame: Single Measurement of 1.5 hours). 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 Feb 2011.