NCT01868607

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

May 30, 2013

Last Update Submit

February 6, 2014

Conditions

Keywords

Respiratory resistanceRespiratory reactanceAdult lung functionForced oscillation techniquesubjects

Outcome Measures

Primary Outcomes (1)

  • Comparison of the respiratory impedance measured with two different FOT devices

    Bland-Altman plot of Zrs measured with two devices

    1 day

Secondary Outcomes (1)

  • Subjective evaluation of the Zrs-measurement with a specific FOT device by the investigated subject.

    1 day

Other Outcomes (1)

  • Effect of the mode of cheek support on the Zrs-measurement

    1 day

Study Arms (1)

Adult lung function

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult subjects and patients with obstructibve lung disease

You may qualify if:

  • Healthy adult subjects
  • Adult patients with obstructive lung disease

You may not qualify if:

  • Inability to perform lung function tests
  • Patients with respiratory failure
  • Patients on BIPAP-therapy
  • Patients on supplemental oxygen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Pulmonary Medicine, Antwerp University Hospital

Edegem-Antwerp, B-2650, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 14680096BACKGROUND
  • 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.

    PMID: 23598954BACKGROUND
  • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

    PMID: 2868172BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Ellie Oostveen, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ellie Oostveen

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 4, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations