Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique Device
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | November 2011 |
| End Date: | May 2014 |
| Contact: | Raffaele L Dellaca', PhD |
| Email: | raffaele.dellaca@polimi.it |
| Phone: | +393804799108 |
Monitoring COPD Patients at Home by a Forced Oscillation Technique Device
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.
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.
The continuous progresses of medical science and technology and the improvement of life
conditions have increased the life expectancy in industrialized countries: the result is the
progressive population aging [UN, 2002]. One of the consequences of this trend is the
increasing number of people suffering from chronic diseases.
Among these pathologies chronic obstructive pulmonary disease (COPD) is the more important
for number of patients and deaths affecting 80 million people in the world [WHO, 2006]. The
time course of the disease is characterized by stable periods broken up by intermittent
acute exacerbations of the symptoms, during which a severe inflammatory process occurs,
leading to increased airways obstruction. During exacerbations the risk of death is very
high [Connors et al, 1996;Soler-Cataluna et al, 2005]. Moreover the frequency and severity
of exacerbations correlate with the worsening of the health condition of the patient
[Anzueto et al, 2009; Donaldson et al, 2002].
The burden of care of patients with COPD on the national health care systems and society is
high. The utilization of health care resources by patients with COPD is primarily due to
acute exacerbations requiring care in the emergency rooms and hospital [Dal Negro, 2008] .
In the last few years the need to rationalize the health care costs has prompted to the
development of new technologies for the home monitoring of these patients mainly aimed at
the early detection of the onset of exacerbations. This could help the development of new
therapeutic and organizational models aimed at reducing the impact of such events on the
quality of life of the patient and on the national health care systems.
Published data offer several different follow-up models of home monitoring of COPD. Written
and electronic diaries, questionnaires, telephonic assistance by respiratory nurses or
specialized clinical personnel and use of web-based call centers have all been suggested for
the follow up of patients after discharge from hospitals. Even if positive results are
reported in terms of reduction of in hospitalization [Vitacca et al, 2009] many COPD
patients tend to underestimate the severity of their condition [Cote et al, 1998] and
patient's compliance in recording their symptoms rapidly decreases with time [Cote et al,
1998]. Moreover, other authors address the difficulty to evaluate correctly the impact of
such models on patient's quality of life and on the reduction of hospitalization and
mortality rate [Ram et al, 2004; Bolton et al, 2010].
An effective home monitoring system for COPD patients should have the following
characteristics:
1. easy to be used in unsupervised environment,
2. able to provide sensible and objective information about patient status,
3. low cost.
Clinically, diagnosis and monitoring of COPD patients is based on spirometric parameters,
such as FEV1 (forced expiratory volume in 1 second), FVC (forced vital capacity) and
FEV1/FVC obtained from forced expiratory maneuvers [Gold, 2009]. However, for most patients
affected by COPD, it is very difficult to execute spirometry correctly because of their poor
ability to perform forced maneuvers. For this reason it is necessary that the test is
supervised by a physician [Miller et al, 2005]. Moreover, there is general belief in the
medical community that FEV1 is insensitive to changes over short periods of time in patients
with COPD so controversy surrounds the reliance of this parameter as an accurate metric for
acute respiratory events.
These may be some of the reasons why most of the studies where patients have been monitored
by home spirometry or peak-flow meters have reported poor results[Brouwer et al, 2010].
A promising technology for the home monitoring of respiratory diseases is represented by the
Forced Oscillations Technique (FOT). FOT is based on the analysis of the response of the
respiratory system to external pressure stimuli superimposed to the spontaneous breathing of
the patient. It does not require the cooperation of the patient and it can provide accurate
measurements even without the supervision of specialized personnel.
In the last few years new technologies based on FOT and special algorithms were developed by
the respiratory research group of the Bioengineering Department of the Politecnico di Milano
University, Italy. These methodologies have been already tested proving to be effective for
the automatic and quantitative evaluation of several phenomena including:
- the presence or not of Expiratory Flow Limitation (EFL) breath by breath [Dellaca' et
al, 2004];
- airways resistance corrected from the artifacts introduced by EFL [Dellaca' et al,
2009];
- the degree of airways heterogeneities measured by the analysis of the frequency
dependency of the resistance;
- the response of the respiratory system to the administration of bronchodilators and
bronchoconstrictors [Dellaca' et al, 2009].
Recently a spin-off company of respiratory group of the Bioengineering Department of the
Politecnico di Milano has made available a special device (RESMONPRO-diary) suitable to
collect data at patient's home without medical supervision. Data from a prototype device
recorded on asthmatic patients have shown its suitability for remote unsupervised monitoring
of chronic conditions.
AIM OF THE STUDY
The aim of the present study is to evaluate the possibility of monitoring oscillatory
parameters of lung mechanics, measured by the Forced Oscillation Technique (FOT), for the
early detection of exacerbations in COPD patients.
Therefore primary outcome will be the identification of the relationship between changes in
patient's symptoms, breathing pattern, lung mechanical impedance indices and occurrence of
and exacerbation.
A further outcome of the study will be the identification and classification of the occurred
exacerbations.
STUDY PROTOCOL
Pre-study measurements:
After the enrollment in the study, every subject will be visited by physician and will
undergo a standard pulmonary function test.
Moreover the following data will be collected:
- exacerbation history
- smoking history
- disease history
- presence of co-morbidities
Daily home monitoring program:
All patients will be monitored at home using a device for oscillometric measurement of lung
functionality (RESMON pro).
The duration of the measurement will be 2-3 minutes once a day for a period comprised
between 6 and 8 months. At the beginning of the measurement the device will ask the patient
to fill a simple questionnaire for self-evaluation of their symptoms (dyspnoea, amount and
purulence of sputum, wheeze, cough). For the duration of the study, the participant will be
asked to wear an Actiwatch Spectrum 24 hours a day. The Actiwatch Spectrum, a small
watch-like device, measures activity by recording and analyzing the readings from the
on-board accelerometer. Each 1-minute activity epoch is analyzed and the statistical results
stored in the on-board memory which can hold up to six-months of data. The Actigraphy data
provides an objective record of activity and has been validated to determine normal and
abnormal sleep / wake patterns.
A nurse will perform a weekly phone interview in order to collect information about presence
and timing of the following events:
- Change in current drug therapy
- Systemic steroids use/prescription
- Antibiotic use/prescription
- Hospitalization due to respiratory causes
- Emergency Room admission
- Unscheduled GP call
- Unscheduled GP visit
- Specialist visit
- Worsening in sleep
- Worsening in dyspnea during daily life activity
- Fever
DATA ANALYSIS
The time-series data and their variability will be analyzed using the method of the time
irreversibility, sample and multiscale entropy, and Gumbel's extreme values statistic. The
predictor of an exacerbation will then be derived by calculating the conditional probability
of having a future acute event given the trend or the variability of indices derived from
the above methods. Additionally data will be analyzed also using a deterministic approach:
linear and non-linear modelling analysis
conditions have increased the life expectancy in industrialized countries: the result is the
progressive population aging [UN, 2002]. One of the consequences of this trend is the
increasing number of people suffering from chronic diseases.
Among these pathologies chronic obstructive pulmonary disease (COPD) is the more important
for number of patients and deaths affecting 80 million people in the world [WHO, 2006]. The
time course of the disease is characterized by stable periods broken up by intermittent
acute exacerbations of the symptoms, during which a severe inflammatory process occurs,
leading to increased airways obstruction. During exacerbations the risk of death is very
high [Connors et al, 1996;Soler-Cataluna et al, 2005]. Moreover the frequency and severity
of exacerbations correlate with the worsening of the health condition of the patient
[Anzueto et al, 2009; Donaldson et al, 2002].
The burden of care of patients with COPD on the national health care systems and society is
high. The utilization of health care resources by patients with COPD is primarily due to
acute exacerbations requiring care in the emergency rooms and hospital [Dal Negro, 2008] .
In the last few years the need to rationalize the health care costs has prompted to the
development of new technologies for the home monitoring of these patients mainly aimed at
the early detection of the onset of exacerbations. This could help the development of new
therapeutic and organizational models aimed at reducing the impact of such events on the
quality of life of the patient and on the national health care systems.
Published data offer several different follow-up models of home monitoring of COPD. Written
and electronic diaries, questionnaires, telephonic assistance by respiratory nurses or
specialized clinical personnel and use of web-based call centers have all been suggested for
the follow up of patients after discharge from hospitals. Even if positive results are
reported in terms of reduction of in hospitalization [Vitacca et al, 2009] many COPD
patients tend to underestimate the severity of their condition [Cote et al, 1998] and
patient's compliance in recording their symptoms rapidly decreases with time [Cote et al,
1998]. Moreover, other authors address the difficulty to evaluate correctly the impact of
such models on patient's quality of life and on the reduction of hospitalization and
mortality rate [Ram et al, 2004; Bolton et al, 2010].
An effective home monitoring system for COPD patients should have the following
characteristics:
1. easy to be used in unsupervised environment,
2. able to provide sensible and objective information about patient status,
3. low cost.
Clinically, diagnosis and monitoring of COPD patients is based on spirometric parameters,
such as FEV1 (forced expiratory volume in 1 second), FVC (forced vital capacity) and
FEV1/FVC obtained from forced expiratory maneuvers [Gold, 2009]. However, for most patients
affected by COPD, it is very difficult to execute spirometry correctly because of their poor
ability to perform forced maneuvers. For this reason it is necessary that the test is
supervised by a physician [Miller et al, 2005]. Moreover, there is general belief in the
medical community that FEV1 is insensitive to changes over short periods of time in patients
with COPD so controversy surrounds the reliance of this parameter as an accurate metric for
acute respiratory events.
These may be some of the reasons why most of the studies where patients have been monitored
by home spirometry or peak-flow meters have reported poor results[Brouwer et al, 2010].
A promising technology for the home monitoring of respiratory diseases is represented by the
Forced Oscillations Technique (FOT). FOT is based on the analysis of the response of the
respiratory system to external pressure stimuli superimposed to the spontaneous breathing of
the patient. It does not require the cooperation of the patient and it can provide accurate
measurements even without the supervision of specialized personnel.
In the last few years new technologies based on FOT and special algorithms were developed by
the respiratory research group of the Bioengineering Department of the Politecnico di Milano
University, Italy. These methodologies have been already tested proving to be effective for
the automatic and quantitative evaluation of several phenomena including:
- the presence or not of Expiratory Flow Limitation (EFL) breath by breath [Dellaca' et
al, 2004];
- airways resistance corrected from the artifacts introduced by EFL [Dellaca' et al,
2009];
- the degree of airways heterogeneities measured by the analysis of the frequency
dependency of the resistance;
- the response of the respiratory system to the administration of bronchodilators and
bronchoconstrictors [Dellaca' et al, 2009].
Recently a spin-off company of respiratory group of the Bioengineering Department of the
Politecnico di Milano has made available a special device (RESMONPRO-diary) suitable to
collect data at patient's home without medical supervision. Data from a prototype device
recorded on asthmatic patients have shown its suitability for remote unsupervised monitoring
of chronic conditions.
AIM OF THE STUDY
The aim of the present study is to evaluate the possibility of monitoring oscillatory
parameters of lung mechanics, measured by the Forced Oscillation Technique (FOT), for the
early detection of exacerbations in COPD patients.
Therefore primary outcome will be the identification of the relationship between changes in
patient's symptoms, breathing pattern, lung mechanical impedance indices and occurrence of
and exacerbation.
A further outcome of the study will be the identification and classification of the occurred
exacerbations.
STUDY PROTOCOL
Pre-study measurements:
After the enrollment in the study, every subject will be visited by physician and will
undergo a standard pulmonary function test.
Moreover the following data will be collected:
- exacerbation history
- smoking history
- disease history
- presence of co-morbidities
Daily home monitoring program:
All patients will be monitored at home using a device for oscillometric measurement of lung
functionality (RESMON pro).
The duration of the measurement will be 2-3 minutes once a day for a period comprised
between 6 and 8 months. At the beginning of the measurement the device will ask the patient
to fill a simple questionnaire for self-evaluation of their symptoms (dyspnoea, amount and
purulence of sputum, wheeze, cough). For the duration of the study, the participant will be
asked to wear an Actiwatch Spectrum 24 hours a day. The Actiwatch Spectrum, a small
watch-like device, measures activity by recording and analyzing the readings from the
on-board accelerometer. Each 1-minute activity epoch is analyzed and the statistical results
stored in the on-board memory which can hold up to six-months of data. The Actigraphy data
provides an objective record of activity and has been validated to determine normal and
abnormal sleep / wake patterns.
A nurse will perform a weekly phone interview in order to collect information about presence
and timing of the following events:
- Change in current drug therapy
- Systemic steroids use/prescription
- Antibiotic use/prescription
- Hospitalization due to respiratory causes
- Emergency Room admission
- Unscheduled GP call
- Unscheduled GP visit
- Specialist visit
- Worsening in sleep
- Worsening in dyspnea during daily life activity
- Fever
DATA ANALYSIS
The time-series data and their variability will be analyzed using the method of the time
irreversibility, sample and multiscale entropy, and Gumbel's extreme values statistic. The
predictor of an exacerbation will then be derived by calculating the conditional probability
of having a future acute event given the trend or the variability of indices derived from
the above methods. Additionally data will be analyzed also using a deterministic approach:
linear and non-linear modelling analysis
Inclusion Criteria:
- COPD at stage 3 and 4 of GOLD classification(spirometric values after bronchodilator:
FEV1/VC < 95th percentile of predicted and FEV1 < 50% of predicted)
- patients who reported more than two exacerbations in the past year OR
- patients who required more than two hospital admission in the last year OR
- patients with ER admission in the last year due to acute respiratory failure
better if:
- depressive phenotype
- worsening of dyspnea during walk (measured by MRC-Medical Research Council score)
- malnutrition or obesity (BMI < 19 or > 25)
- patient lives alone
Exclusion Criteria:
- Other respiratory diseases
- Alpha-1antitrypsin deficiency
- Significant inflammatory diseases other than COPD
- Organ or systemic diseases that may impair the ventilatory function (any restrictive
pulmonary disease, cystic fibrosis and so on)
- Prior lung surgery
- Concomitant enrollment in other trials
- Any major non-COPD disease or condition, such as uncontrolled malignancy, end-stage
heart disease, liver or renal insufficiency (that requires current evaluation for
liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe
stroke, or other as deemed appropriate by investigator as determined by review of
medical history and / or patient reported medical history
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