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

NCT ID: NCT00499304

Last Updated: 2008-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-04-30

Brief Summary

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.

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.

Conditions

COPD

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Center Alkmaar

OTHER

Sponsor Role: lead

Principal Investigators

Dewi Tjiong, drs

Role: PRINCIPAL_INVESTIGATOR

Medical Center Alkmaar

Locations

Medical Center Alkmaar

Alkmaar, , Netherlands

Countries

Netherlands

Other Identifiers

NL13873.09406

Identifier Type: -

Identifier Source: org_study_id