Reliability of Different FOT Devices to Measure the Human Respiratory Impedance

NCT ID: NCT01868607

Last Updated: 2014-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-01-31

Brief Summary

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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

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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

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Pulmonary Disease Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adult lung function

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Ellie Oostveen

Professor Ellie Oostveen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellie Oostveen, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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Dept. of Pulmonary Medicine, Antwerp University Hospital

Edegem-Antwerp, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 14680096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23598954 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2868172 (View on PubMed)

Other Identifiers

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FOT_UZA_2013

Identifier Type: -

Identifier Source: org_study_id

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