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Forced Oscillation Technique (FOT) and Expiratory Flow Limitation (EFL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00499304
First Posted: July 11, 2007
Last Update Posted: June 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical Center Alkmaar
  Purpose
The aim of this study is to distinguish COPD patients with expiratory flow limitation in body plethysmography (open loop) from the patients without expiratory flow limitation in body plethysmography (closed loop) with the obtained FOT parameters.

Condition
COPD

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diagnosing Expiratory Flow Limitation in COPD Patients With the Forced Oscillation Technique Using Linear Regression in the Time Frequency Domain

Further study details as provided by Medical Center Alkmaar:

Estimated Enrollment: 60
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:
In daily practice the expiratory flow limitation is measured by body plethysmography. An open loop in body plethysmography shows expiratory flow limitation in COPD patients. But body plethysmography requires that the patient quietly sits in a closed box and is not able to follow changes breath by breath. The goal of this study is to validate the Forced oscillation technique (FOT) for measuring expiratory flow limitation in COPD patients.30 COPD patients with an open loop in body plethysmography are compared to 30 COPD patients with a closed loop. The methods used in this study are the maximal overlap discrete short time Fourier transform (MODFT) combined with a total least squares analysis. It is hypothesized that the obtained FOT parameters are able to distinguish the patients with expiratory flow limitation in body plethysmography from the patients without expiratory flow limitation in body plethysmography.Secondary study questions are: 1) to what extend are the FOT parameters distorted by breathing artifacts and measurement noise. 2)What changes can be detected by FOT in expiratory flow limitation after administration of salbutamol.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Stable GOLD 2-4 COPD patients
Criteria

Inclusion Criteria:

  • Presenting to the outpatient clinic
  • Age 50-80 years
  • Diagnosed with COPD according to the standard criteria
  • Gold Stage II to IV COPD
  • Current or ex-smokers (at least 10 PY)
  • Stable disease (No current exacerbation or exacerbation during the 4 weeks previous to the inclusion)

Exclusion Criteria:

  • History of exacerbation of COPD in the preceding month
  • Upper airway obstruction
  • Allergic Asthma
  • OSAS (obstructive sleep apnea syndrome)
  • Extreme obesity (BMI>35)
  • Clinically manifest cardiac disease (for example clinically relevant congestive heart failure, unstable angina pectoris)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499304


Locations
Netherlands
Medical Center Alkmaar
Alkmaar, Netherlands, 1815JD
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
Principal Investigator: Dewi Tjiong, drs Medical Center Alkmaar
  More Information

ClinicalTrials.gov Identifier: NCT00499304     History of Changes
Other Study ID Numbers: NL13873.09406
First Submitted: July 10, 2007
First Posted: July 11, 2007
Last Update Posted: June 6, 2008
Last Verified: June 2008

Keywords provided by Medical Center Alkmaar:
Forced oscillation Technique (FOT)
Expiratory flow limitation (EFL)
Breathing artifacts
COPD