Clinical trial NCT01868607: Reliability of Different FOT Devices to Measure the Human Respiratory Impedance
Official title: Comparison of the Reliability of Different Devices to Measure Lung Function With the Forced Oscillation Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Healthy
Keywords: Respiratory resistance
Respiratory reactance
Adult lung function
Forced oscillation technique
subjects
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult subjects and patients with obstructibve lung disease

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.

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?

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects
* Adult patients with obstructive lung disease

Exclusion Criteria:

* Inability to perform lung function tests
* Patients with respiratory failure
* Patients on BIPAP-therapy
* Patients on supplemental oxygen.

Primary outcomes:
measure: Comparison of the respiratory impedance measured with two different FOT devices
timeFrame: 1 day
Secondary outcomes:
measure: Subjective evaluation of the Zrs-measurement with a specific FOT device by the investigated subject.
timeFrame: 1 day
Other outcomes:
measure: Effect of the mode of cheek support on the Zrs-measurement
timeFrame: 1 day
Locations:
city: Edegem-Antwerp
country: Belgium
facility: Dept. of Pulmonary Medicine, Antwerp University Hospital
Study officials:
affiliation: University Hospital, Antwerp
name: Ellie Oostveen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Oostveen 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.
citation: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.