Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique Device
Recruitment status was: Recruiting
Chronic obstructive pulmonary disease (COPD) is a pathological condition whose progression is characterized by stable periods broken up by intermittent acute exacerbations of the symptoms, during which a severe inflammatory process occurs often requiring hospitalization. During exacerbations the risk of death is very high making the social and economical impact of such events important.
The need of rationalize the utilization of health care resources together with the optimization of patient's care has prompted the development of models of assistance based on home monitoring. At the present time most of the suggested models were based on the utilization of diaries for symptoms perceived by the patients. Even if positive results are reported in terms of reduction of in hospitalization many COPD patients tend to underestimate the severity of their condition and their compliance in recording their symptoms rapidly decreases with time.
Attempts of using more objective measurements such as home spirometers have been done but poor results were reported mainly due to the difficulties in performing a spirometric test without medical supervision.
A more suitable approach to get objective information on the function of the respiratory system is the Forced Oscillation Technique (FOT). Such methodology is based on the analysis of the response of the system to small pressure stimuli over-imposed to the normal breathing of the patients. The measurements require minimal cooperation and can be performed without medical supervision.
The purpose of this study is to measure daily variability of FOT data measured at home of a group of COPD patients in order to identify possible correlations between symptoms change, breathing pattern, lung mechanical impedance and occurrence of exacerbation.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Monitoring COPD Patients at Home by a Forced Oscillation Technique Device|
- Day-by-day changes of lung mechanical impedance [ Time Frame: Every day for 8 months ] [ Designated as safety issue: No ]Changes in within-breath total respiratory input impedance (Zrs), resistance (Rrs) and Reactance (Xrs) measured day-by-day by the RESMONPRO device
- Day-by-day changes of patient's symptom [ Time Frame: Every day for 8 months ] [ Designated as safety issue: No ]Changes of perceived symptoms as reported by the patients no the RESMONPRO device
- Day-by-day changes of patient activity [ Time Frame: Every day for 8 months ] [ Designated as safety issue: No ]level of activity of the patient as recorded by the Actiwatch.
- Number of exacerbation [ Time Frame: 8 months ] [ Designated as safety issue: No ]
On the basis of the presence of the following events an exacerbation will be detected and classified as:
Mild exacerbation: changes in current treatment or prescription of a short acting bronchodilator Intermediate exacerbation: prescription of a steroids per os Severe exacerbation: prescription of systemic antibiotic Very severe exacerbation: hospital admission
- Day-by-day changes of breathing pattern [ Time Frame: Every day for 8 months ] [ Designated as safety issue: No ]Changes in breathing pattern measured while performing FOT by RESMONPRO device
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552031
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, Texas, United States, 77030|
|Divisione di Pneumologia, Fondazione S. Maugeri, IRCCS|
|Lumezzane, BS, Italy|
|Pneumologia-Fisiopatologia Respiratoria, Azienda Ospedaliera S. Luigi Gonzaga|
|Orbassano, Torino, Italy|
|Unità Operativa di Riabilitazione Pneumologica, Fondazione S. Maugeri, IRCCS|
|Pavia, Italy, 27100|
|U.O. Pneumologia - A.O. Ospedale di Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Principal Investigator:||Raffaele L Dellaca', PhD||Politecnico di Milano, Italy|
|Principal Investigator:||Michele Vitacca, MD||Pneumology Division Fondazione Salvatore Maugeri, IRCCS, Lumezzane, Italy|
|Principal Investigator:||Alessandro Gobbi, PhD||Politecnico di Milano, Italy|
|Principal Investigator:||Pasquale P Pompilio, PhD||Politecnico di Milano, Italy|
|Principal Investigator:||Emanuela Zannin, PhD||Politecnico di Milano, Italy|
|Principal Investigator:||Carlo Gulotta, MD||Pneumologia-Fisiopatologia Respiratoria, Azienda Ospedaliera S. Luigi Gonzaga Orbassano, Torino, Italy|
|Principal Investigator:||Amir Sharafkhaneh, MD, PhD||Sleep Disorders & Research Center Michael E. DeBakey VA Medical Center|
|Principal Investigator:||Piero Ceriana, MD||Unità Operativa di Riabilitazione Pneumologica, Fondazione Salvatore Maugeri, IRCCS, Pavia, Italy|
|Principal Investigator:||Fausto Colombo, MD||Direttore U.O. Pneumologia - A.O. Ospedale di Circo lo e Fondazione Macchi, Varese|