Obstructive Lung DiseasesEIT-LungeNCT02290535
Electrical Impedance Tomography of Lung in Child and Young Age
An observational study of Obstructive Lung Diseases, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The investigator will determine a compliance of two diagnostic techniques (EIT and Body plethysmography) in collective of children and teenagers with obstructive lung disease and a matched control group. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Lung Diseases
- What is being tested?
- patients and probands
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Jan 2015
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients, who come to the consultation to the Department of Pediatric Pneumology, Children and Adolescent Medicine, University Hospital Aachen, will be recruited and divided into groups by age and diagnosis. Recriutment will be performed in accordance to the inclusion and exclusion criteria.
Who may be able to join
- Patients: children and teenagers with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive brochitis, obstructive pneumonia).
- Probands: Children and Teenager of 5-18 years without known obstructive pulmonary diseases
Who cannot join
- active implants (ICD, CRT)
- metal in chest
- artificial heart valve
- children < 5 years
- pregnant and lactating females
- Persons, who are in relationship of dependence to the investigator / sponsor
- Persons, who are not able to understand and follow the instructions of the study personnel.
- Lack of signed informed consent (by legal guardian /proband)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
The investigator will determine a compliance of two diagnostic techniques (EIT and Body plethysmography) in collective of children and teenagers with obstructive lung disease and a matched control group.
Read the detailed description
The aim of the present study is verification of the correlation between EIT-derived data and following extracted parameters of the pulmonary function:
- forced expiratory volume in 1 second (FEV 1)
- forced vital capacity (FVC)
- relative forced expiratory volume in 1 second (FEV1/FVC)
- maximal expiratory flow (MEF 25)
- total lung capacity (TLC)
- resistance (Raw).
These findings could bring out new prospective opportunity for pulmonary function tests without cooperation.
Furthermore, the study aims to clarify whether EIT technique can be used for regional pulmonary function testing.
In addition, dynamic lung function parameter and static radiological techniques will be correlated with EIT.
- Conditions
- Obstructive Lung Diseases
- Being tested
- patients, probands
- Keywords
- obstructive pulmonary disease, children, teenager, EIT (Electrical Impedance Tomography)
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patientsProcedure or surgery
The 16-electrode belt will be applied to patient's chest. Following vital signs will be recorded: respiratory rate at rest breathing, heart rate, transcutaneous oxygen saturation. Then impulse oscillometry (IOS) will be performed in a sitting position. After that, subjects with cooperation willingness will get a body plethysmography. A spirometry / forced breathing maneuvers will be performed. All patients will receive 2 strokes salbutamol inhaler for bronchospasmolysis. Please note that inhalation of salbutamol is not study related. It is used in the clinical routine to examine the reversibility of the bronchial obstruction in patients with obstructive lung disease in course of the lung function test. Ten minutes later measurements described above will be repeated.
probandsProcedure or surgery
Probands will receive the same treatment as patients, but without bronchospasmolysis.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Children and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia). Receives: Procedure: patients | |
| Probands | Children and Teenager of 5-18 years without known obstructive pulmonary diseases Receives: Procedure: probands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01)
The robustness of ΔZFEV1.0 (= change in electrical impedance based on the FVC FEV1.0) and τ (= mechanical time constant τ which classifies the regional and global lung mechanics) and their clinical relevance will be investigated.
Measured: Baseline
Secondary outcomes (3)
Correlation between lung function parameters and extracted parameters of the EIT.
The present study aims to verify, whether a correlation between lung function parameters and extracted parameters of the EIT exists.
Measured: Baseline
EIT as a diagnostic method for assessment of lung function
It will be examined, whether single EIT measurement can be used for assessment of the lung function.
Measured: Baseline
Regional mechanical transmission behavior
Another secondary outcome is the local mechanical transmission behavior as an index of pulmonary status. By using the correlation between results gained from EIT and results from impulse oscillometry (IOS) differentiation between central and peripheral obstruction of respiratory tracts will be proved.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Lung DiseasesStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia Lehmann, MD, Principal investigator, Unversity Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290535
- Sponsor's protocol ID
- 12-076
- Other IDs
- CIV-14-03-011942
- Acronym
- EIT-Lunge
- Status last verified
- Jul 2015
- First submitted
- 19 Sep 2014
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography of Lung in Child and Young Age
- ClinicalTrials.gov ID
- NCT02290535
- Acronym / sponsor ID
- EIT-Lunge / 12-076
- Conditions
- Obstructive Lung Diseases
- Keywords
- obstructive pulmonary disease, children, teenager, EIT (Electrical Impedance Tomography)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Nov 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 investigator will determine a compliance of two diagnostic techniques (EIT and Body plethysmography) in collective of children and teenagers with obstructive lung disease and a matched control group.
Detailed description
The aim of the present study is verification of the correlation between EIT-derived data and following extracted parameters of the pulmonary function:
- forced expiratory volume in 1 second (FEV 1)
- forced vital capacity (FVC)
- relative forced expiratory volume in 1 second (FEV1/FVC)
- maximal expiratory flow (MEF 25)
- total lung capacity (TLC)
- resistance (Raw).
These findings could bring out new prospective opportunity for pulmonary function tests without cooperation.
Furthermore, the study aims to clarify whether EIT technique can be used for regional pulmonary function testing.
In addition, dynamic lung function parameter and static radiological techniques will be correlated with EIT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: patientsChildren and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia). |
| Probands | – | Procedure: probandsChildren and Teenager of 5-18 years without known obstructive pulmonary diseases |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients, who come to the consultation to the Department of Pediatric Pneumology, Children and Adolescent Medicine, University Hospital Aachen, will be recruited and divided into groups by age and diagnosis. Recriutment will be performed in accordance to the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Patients: children and teenagers with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive brochitis, obstructive pneumonia).
- Probands: Children and Teenager of 5-18 years without known obstructive pulmonary diseases
Key exclusion criteria (8 listed)
- active implants (ICD, CRT)
- metal in chest
- artificial heart valve
- children < 5 years
- pregnant and lactating females
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 |
|---|---|---|
| patientsThe 16-electrode belt will be applied to patient's chest. Following vital signs will be recorded: respiratory rate at rest breathing, heart rate, transcutaneous oxygen saturation. Then impulse oscillometry (IOS) will be performed in a sitting position. After that, subjects with cooperation willingness will get a body plethysmography. A spirometry / forced breathing maneuvers will be performed. All patients will receive 2 strokes salbutamol inhaler for bronchospasmolysis. Please note that inhalation of salbutamol is not study related. It is used in the clinical routine to examine the reversibility of the bronchial obstruction in patients with obstructive lung disease in course of the lung function test. Ten minutes later measurements described above will be repeated. | Procedure or surgery | Patients |
| probandsProbands will receive the same treatment as patients, but without bronchospasmolysis. | Procedure or surgery | Probands |
Primary outcome
Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01)
Time frame: Baseline
The robustness of ΔZFEV1.0 (= change in electrical impedance based on the FVC FEV1.0) and τ (= mechanical time constant τ which classifies the regional and global lung mechanics) and their clinical relevance will be investigated.
3 secondary outcomes
Correlation between lung function parameters and extracted parameters of the EIT.
Time frame: Baseline
EIT as a diagnostic method for assessment of lung function
Time frame: Baseline
Regional mechanical transmission behavior
Time frame: Baseline
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 16 Jul 2015.
Related trials for Obstructive Lung Diseases
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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.
Sylvia Lehmann, MD principal investigator
Unversity Hospital Aachen
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 Obstructive Lung Diseases, 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 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: finished, as of the sponsor's last update on 16 Jul 2015. 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?
Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01) (time frame: Baseline). 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 Jul 2015.