Reliability of Different FOT Devices to Measure the Human Respiratory Impedance

Healthy Clinical Trial

Official title:

Comparison of the Reliability of Different Devices to Measure Lung Function With the Forced Oscillation Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868607
• Other study ID #: FOT_UZA_2013
• Status: Completed
• Phase: N/A
• First received: May 30, 2013
• Last updated: February 6, 2014
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy
• Pulmonary Disease

Locations

Country	Name	City	State
Belgium	Dept. of Pulmonary Medicine, Antwerp University Hospital	Edegem-Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View 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. — View Citation

Oostveen E, MacLeod D, Lorino H, Farré 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of the mode of cheek support on the Zrs-measurement	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.	1 day	No
Primary	Comparison of the respiratory impedance measured with two different FOT devices	Bland-Altman plot of Zrs measured with two devices	1 day	No
Secondary	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	1 day	No