- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00844116
Efficacy of "On Line" Telematic Spirometry
May 15, 2012 updated by: Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
The investigators aim to demonstrate that spirometry performed "on line" with a technician in a remote place from the patient has the same efficacy as the one performed personally.
As a previous study the investigators analyzed the inter-observer agreement between two pulmonary function technicians from both centers taking part in the study: San Pedro de Alcántara Hospital (Cáceres) and Carlos III hospital (Madrid).
The main study will be broad (226 patients derivates from primary care to pneumology consultation), prospective, aleatorized, crossed, blind and controlled.
The patients will be aleatorized in two groups: 1) personal spirometry: performed in a conventional way; 2) telematic spirometry: performed remotely "on line".
The same pulmonary function technician, who will carry out the spirometries personally, will be located in a nearly room.
The technician will control the computer office and the spirometer software in the patients's room with another computer.
By means of teleconference, the technician will indicate the patient to start the maneuver.
After 20 minutes from the end of the first spirometry, the patients will complete the protocol of the following group.
The mean values of FVC, FEV1 and FEV1/FVC, the mean time of spirometry performance, the mean number of spirometric maneuvers performed, are compared between both groups by t proof for paired data.
The comparison of the percentage of proofs with non acceptability or reproducibility criteria will be made by X2 test.
The analysis will be made blindly.
The inter-observer and intra-observer agreement will be evaluated by analysis of intraclass correlation for FVC and FEV1 values.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
226
Phase
- Not Applicable
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
-
-
-
Cáceres, Spain, 10003
- Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
-
-
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
14 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 14 and 70 years.
- Patients referred for pulmonary consultation from primary care center.
Exclusion Criteria:
- Psychophysical incapacity to performed spirometry.
- Informed consent not obtained.
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional Spirometry
personal spirometry
|
Conventional and telematic spirometry
|
Experimental: Telematic Spirometry
performed remotely "on line"
|
Conventional and telematic spirometry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The spirometry performed "on line" with a technician in a remote place from the patient has the same efficacy as the one performed personally and FEV1 and FVC
Time Frame: at the end of the study
|
at the end of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Nº total test feasible Nº total of test Percentage of cases excluded(dropouts) for failure to obstain three acceptable and two reproducibles test
Time Frame: at the end of the study
|
at the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Juan F. Masa, M.D, Hospital San Pedro de Alcántara. Cáceres. Spain
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
January 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
February 12, 2009
First Submitted That Met QC Criteria
February 12, 2009
First Posted (Estimate)
February 13, 2009
Study Record Updates
Last Update Posted (Estimate)
May 16, 2012
Last Update Submitted That Met QC Criteria
May 15, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI040727
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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