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Completed

NCT Number: NCT01868607

Reliability of Different FOT Devices to Measure the Human Respiratory Impedance

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

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Key information

Conditions

Pulmonary Disease Healthy Lung Diseases Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Pulmonary Medicine, Antwerp University Hospital

Edegem-Antwerp, B-2650, Belgium

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Comparison of the respiratory impedance measured with two different FOT devices

    Time frame: 1 day

    Bland-Altman plot of Zrs measured with two devices

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2013
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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