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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01868607

Enrollment

Registered

2013-06-04

Start date

2013-06-30

Completion date

2014-01-31

Last updated

2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Pulmonary Disease

Keywords

Respiratory resistance, Respiratory reactance, Adult lung function, Forced oscillation technique, subjects

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?

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Comparison of the respiratory impedance measured with two different FOT devices	1 day	Bland-Altman plot of Zrs measured with two devices

Secondary

Measure	Time frame	Description
Subjective evaluation of the Zrs-measurement with a specific FOT device by the investigated subject.	1 day	Rating of the subjective experience of the Zrs-measurement with a specific FOT device

Other

Measure	Time frame	Description
Effect of the mode of cheek support on the Zrs-measurement	1 day	The effect of two modes of cheek support on the Zrs-estimate will be assessed in each investigated subject with one (randomly chosen) FOT-device.

Countries

Belgium

Outcome results