Efficacy of "On Line" Telematic Spirometry

NCT00844116 | Completed

• 1 other identifier: PI040727
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; spirometry; Telematic spirometry

Outcome Measures

Primary Outcomes (1)

• 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

  at the end of the study

Secondary Outcomes (1)

• Nº total test feasible Nº total of test Percentage of cases excluded(dropouts) for failure to obstain three acceptable and two reproducibles test

  at the end of the study

Study Arms (2)

Conventional Spirometry

ACTIVE COMPARATOR

personal spirometry

Device: spirometry

Telematic Spirometry

EXPERIMENTAL

performed remotely "on line"

Device: spirometry

Interventions

spirometry DEVICE

Conventional and telematic spirometry

Conventional Spirometry; Telematic Spirometry

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 14 and 70 years.
• Patients referred for pulmonary consultation from primary care center.

You may not qualify if:

• Psychophysical incapacity to performed spirometry.
• Informed consent not obtained.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Cáceres, Cáceres, 10003, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Juan F. Masa, M.D

  Hospital San Pedro de Alcántara. Cáceres. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

ES (1)