Chest Wall Disorders, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease, Obesity Hypoventilation Syndrome
Conditions
Keywords
Chronic respiratory failure, Noninvasive Mechanical Ventilation, Home-care, Telemedicine, COPD
Brief summary
The critical nature of respiratory diseases, the continuously increasing prevalence of these conditions, and the subjective perception of patients vis-à-vis their pulmonary function and health status underscore the importance of home telemonitoring. These conditions are critical and necessitate close and regular monitoring that may be achieved at distance using telemonitoring. This study will assess a number of measures both at baseline and post-intervention from a number of domains, including Arterial Blood Gases (ABG), BiPAP-related data, chronic respiratory failure symptoms, health-related quality of life, patients satisfaction and utilization of healthcare resources.
Detailed description
In recent years home care is becoming increasingly used and considered by some the future of healthcare. Home mechanical ventilation has been shown to improve morbidity and mortality in patients with chronic respiratory failure of different aetiologies. A French survey suggests an increase of 12% of cases per year. With the prospect of a substantial increase of ventilated patients at home, facilities and resources have not been proportionally growing, so new approaches should be investigated and addressed to absorb this constant flux of patients. Telemedicine is defined as the broad use of electronic and communications technologies to provide and support remote monitoring of health status. It has been shown to be an effective alternative model of care for managing chronic diseases. It as also been shown to reduce healthcare costs and is a major topic on the agendas of health and social care policies in Europe. Home telemonitoring of respiratory conditions results in early identification of deteriorations in patient condition and symptom control. However, evidence on the magnitude of clinical and structural effects remains preliminary, with variations in study approaches and an absence of robust study designs and formal evaluations. The objective is gathering data that can be help to establish guidelines for non invasive home mechanical ventilation initiation and quality control.
Interventions
DEVICETelemonitoring tools
Patients will go home with telemedicine tools to monitor efficacy and compliance of non-invasive home mechanical ventilation
DEVICEUsual Care
The assessment of efficacy and compliance will be monitor at the end of third month. This is the date of the scheduled hospital visit.
Sponsors
Hospital Sao Joao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
OHS: * PaCO2 \> 45 mmHg; * IMC \> 40 Kg/m2 COPD: * Age \< 80 years; * Receiving appropriate medical therapy according to gold guidelines * Long-term oxygen therapy (LTOT) for at least 3 months; * PaCO2 \> 50 mmHg during room air * ph \> 7,35 and free from exacerbations in the 4 weeks preceding recruitment; * One exacerbation in the last year before preceding recruitment with necessity of NIV in the acute care setting; * FEV1 \< 1,5l or \< 50% predicted; * FEV1/FVC \< 60% * Total Lung Capacity (TLC)≥ 90% predicted; * PaO2 \< 60 mmHg breathing room air at rest. NMD and CWD: * PaCO2 \> 45 mmHg; * Significant nocturnal desaturation * FVC \< 50% predicted; * SNIP \< 40 cmH20 * MIP \< 60% predicted * Ortopnea; * 20% drop of VC in supine position.
Exclusion criteria
OHS: * COPD * NMD COPD: * 15% increase in FEV1 after inhaled Salbutamol (200 µg); * Active smoking; * History of OSA (with AHI \> 15 episodes.h-1) NMD and CWD: * COPD; * OHS; * PCF \< 270; * Severe bulbar weakness (ALSFRS bulbar subscore 0-3) * MIC/VC=1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal noninvasive ventilation compliance per day | 9 months | We aim to detect a difference of 1 hour in the mean of nightly hours of use, assuming a standard deviation (SD) of 2 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Economics Evaluation | 9 months | This project project will randomize 2 distinct groups adopting different tecnhologies so we will be able to quantify the economic/budget impacts for each alternative |
| Health related Quality of Life | 9 months | Incremental gains in quality of life will be evalueted from a clinical perspective and as an investment. |
| Arterial Blood Gases | 9 months | We aim to detect a |
Countries
Portugal
Contacts
Primary ContactJoão Carlos Winck, PhD
Backup ContactMiguel Gonçalves, PhD
Outcome results
None listed