Clinical trial NCT01560741: Telemedicine and Ventilator Titration in Chronic Respiratory Patients Initiating Non-invasive Ventilation
Official title: Randomized Trial Comparing Telemedicine Monitoring and Titration in Patients Initiating Non-invasive Ventilation With Usual Care (TELEMOTINIV Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Neuromuscular Disease
Chest Wall Disorders
Obesity Hypoventilation Syndrome
Keywords: Chronic respiratory failure
Noninvasive Mechanical Ventilation
Home-care
Telemedicine
COPD
Lead sponsor: Hospital Sao Joao
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 128
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nocturnal noninvasive ventilation compliance per day
timeFrame: 9 months
Secondary outcomes:
measure: Health Economics Evaluation
timeFrame: 9 months
measure: Health related Quality of Life
timeFrame: 9 months
measure: Arterial Blood Gases
timeFrame: 9 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Hospital de S.João
Study officials:
affiliation: Hospital de S. João
name: J C Winck, Phd
role: PRINCIPAL_INVESTIGATOR
References: