Efficacy of "On Line" Telematic Spirometry
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Device: spirometry |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Efficacy of "On Line" Telematic Spirometry |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 226 |
| Study Start Date: | January 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Conventional Spirometry
personal spirometry
|
Device: spirometry
Conventional and telematic spirometry
|
|
Experimental: Telematic Spirometry
performed remotely "on line"
|
Device: spirometry
Conventional and telematic spirometry
|
Eligibility| Ages Eligible for Study: | 14 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Spain | |
| Hospital San Pedro de Alcántara. Servicio Extremeño de Salud | |
| Cáceres, Spain, 10003 | |
| Principal Investigator: | Juan F. Masa, M.D | Hospital San Pedro de Alcántara. Cáceres. Spain |
More Information
No publications provided
| Responsible Party: | Juan F. Masa, MD, Sociedad Española de Neumología y Cirugía Torácica |
| ClinicalTrials.gov Identifier: | NCT00844116 History of Changes |
| Other Study ID Numbers: | PI040727 |
| Study First Received: | February 12, 2009 |
| Last Updated: | May 15, 2012 |
| Health Authority: | Spain: Ministry of Health and Consumption |
Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
|
COPD spirometry Telematic spirometry |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013