Pulmonary DiseaseNCT01868607
Reliability of Different FOT Devices to Measure the Human Respiratory Impedance
An observational study of Pulmonary Disease and Healthy, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The objective of the study is to evaluate the reliability of the impedance data in adult subjects measured with five different FOT devices. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Healthy
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2013to Jan 2014
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult subjects and patients with obstructibve lung disease
Who may be able to join
- Healthy adult subjects
- Adult patients with obstructive lung disease
Who cannot join
- Inability to perform lung function tests
- Patients with respiratory failure
- Patients on BIPAP-therapy
- Patients on supplemental oxygen.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Dept. of Pulmonary Medicine, Antwerp University Hospital
Edegem-Antwerp, B-2650
About this study
Official title: Comparison of the Reliability of Different Devices to Measure Lung Function With the Forced Oscillation Technique
The objective of the study is to evaluate the reliability of the impedance data in adult subjects measured with five different FOT devices.
Read the detailed description
The purpose of the study is to evaluate the reliability of the respiratory impedance measured with different FOT (=Forced Oscillation Technique) devices. To this end, the respiratory impedance of fifty adult subjects will be measured in random order with five different forced oscillation devices. As there is no "gold standard" FOT-device, each setup will be compared to all other setups.
Secondary study questions are: 1) is there a specific comfort (or discomfort) associated with the different measuring devices 2) Guidelines state that full chin and cheek support should be applied when measuring the human respiratory impedance. What is the influence of a partial cheek support?
- Conditions
- Pulmonary Disease, Healthy
- Keywords
- Respiratory resistance, Respiratory reactance, Adult lung function, Forced oscillation technique, subjects
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult lung function | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the respiratory impedance measured with two different FOT devices
Bland-Altman plot of Zrs measured with two devices
Measured: 1 day
Secondary outcomes (1)
Subjective evaluation of the Zrs-measurement with a specific FOT device by the investigated subject.
Rating of the subjective experience of the Zrs-measurement with a specific FOT device
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellie Oostveen, University Hospital, Antwerp
- Investigators
- Ellie Oostveen, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868607
- Sponsor's protocol ID
- FOT_UZA_2013
- Status last verified
- Feb 2014
- First submitted
- 30 May 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
PubMed 14680096Oostveen E, Boda K, van der Grinten CP, James AL, Young S, Nieland H, Hantos Z. Respiratory impedance in healthy subjects: baseline values and bronchodilator response. Eur Respir J. 2013 Dec;42(6):1513-23. doi: 10.1183/09031936.00126212. Epub 2013 Apr 18.
PubMed 23598954Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Reliability of Different Devices to Measure Lung Function With the Forced Oscillation Technique
- ClinicalTrials.gov ID
- NCT01868607
- Acronym / sponsor ID
- FOT_UZA_2013
- Conditions
- Pulmonary Disease, Healthy
- Keywords
- Respiratory resistance, Respiratory reactance, Adult lung function, Forced oscillation technique, subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Jun 2013 (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 objective of the study is to evaluate the reliability of the impedance data in adult subjects measured with five different FOT devices.
Detailed description
The purpose of the study is to evaluate the reliability of the respiratory impedance measured with different FOT (=Forced Oscillation Technique) devices. To this end, the respiratory impedance of fifty adult subjects will be measured in random order with five different forced oscillation devices. As there is no "gold standard" FOT-device, each setup will be compared to all other setups.
Secondary study questions are: 1) is there a specific comfort (or discomfort) associated with the different measuring devices 2) Guidelines state that full chin and cheek support should be applied when measuring the human respiratory impedance. What is the influence of a partial cheek support?
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult lung function | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult subjects and patients with obstructibve lung disease
Key inclusion criteria (2 listed)
- Healthy adult subjects
- Adult patients with obstructive lung disease
Key exclusion criteria (4 listed)
- Inability to perform lung function tests
- Patients with respiratory failure
- Patients on BIPAP-therapy
- Patients on supplemental oxygen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the respiratory impedance measured with two different FOT devices
Time frame: 1 day
Bland-Altman plot of Zrs measured with two devices
1 secondary outcome
Subjective evaluation of the Zrs-measurement with a specific FOT device by the investigated subject.
Time frame: 1 day
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 7 Feb 2014.
- Background: PubMed 14680096Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
- Background: PubMed 23598954Oostveen E, Boda K, van der Grinten CP, James AL, Young S, Nieland H, Hantos Z. Respiratory impedance in healthy subjects: baseline values and bronchodilator response. Eur Respir J. 2013 Dec;42(6):1513-23. doi: 10.1183/09031936.00126212. Epub 2013 Apr 18.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
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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.
Ellie Oostveen, PhD principal investigator
University Hospital, Antwerp
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 Pulmonary Disease and Healthy, run by University Hospital, Antwerp at 1 site in Belgium.
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: finished, as of the sponsor's last update on 7 Feb 2014. 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 Belgium. 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?
Comparison of the respiratory impedance measured with two different FOT devices (time frame: 1 day). 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 NCT01868607, which also lists 3 linked publications.
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 7 Feb 2014.