Reliability of Different FOT Devices to Measure the Human Respiratory Impedance
Comparison of the Reliability of Different Devices to Measure Lung Function With the Forced Oscillation Technique
1 other identifier
observational
80
1 country
1
Brief Summary
The objective of the study is to evaluate the reliability of the impedance data in adult subjects measured with five different FOT devices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFebruary 7, 2014
February 1, 2014
7 months
May 30, 2013
February 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of the respiratory impedance measured with two different FOT devices
Bland-Altman plot of Zrs measured with two devices
1 day
Secondary Outcomes (1)
Subjective evaluation of the Zrs-measurement with a specific FOT device by the investigated subject.
1 day
Other Outcomes (1)
Effect of the mode of cheek support on the Zrs-measurement
1 day
Study Arms (1)
Adult lung function
Eligibility Criteria
Healthy adult subjects and patients with obstructibve lung disease
You may qualify if:
- Healthy adult subjects
- Adult patients with obstructive lung disease
You may not qualify if:
- Inability to perform lung function tests
- Patients with respiratory failure
- Patients on BIPAP-therapy
- Patients on supplemental oxygen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Pulmonary Medicine, Antwerp University Hospital
Edegem-Antwerp, B-2650, Belgium
Related Publications (3)
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.
PMID: 14680096BACKGROUNDOostveen 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.
PMID: 23598954BACKGROUNDBland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PMID: 2868172BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellie Oostveen, PhD
University Hospital, Antwerp
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Ellie Oostveen
Study Record Dates
First Submitted
May 30, 2013
First Posted
June 4, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
February 7, 2014
Record last verified: 2014-02