Reliability of Different FOT Devices to Measure the Human Respiratory Impedance

February 6, 2014 updated by: Ellie Oostveen, University Hospital, Antwerp

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

The objective of the study is to evaluate the reliability of the impedance data in adult subjects measured with five different FOT devices.

Study Overview

Status

Completed

Conditions

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?

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem-Antwerp, Belgium, B-2650
        • Dept. of Pulmonary Medicine, Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adult subjects and patients with obstructibve lung disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adult lung function

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the mode of cheek support on the Zrs-measurement
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Ellie Oostveen, PhD, University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOT_UZA_2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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