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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01560741
Other study ID # TeleMotiNIV2012
Secondary ID
Status Recruiting
Phase Phase 1
First received March 20, 2012
Last updated October 3, 2012
Start date July 2012
Est. completion date May 2013

Study information

Verified date October 2012
Source Hospital Sao Joao
Contact João Carlos Winck, PhD
Phone +351 225 512 100
Email jcwfc@hsjoao.min-saude.pt
Is FDA regulated No
Health authority Portugal: Ethics Committee for Clinical Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date May 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Intervention

Device:
Telemonitoring tools
Patients will go home with telemedicine tools to monitor efficacy and compliance of non-invasive home mechanical ventilation
Usual 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.

Locations

Country Name City State
Portugal Hospital de S.João Porto

Sponsors (1)

Lead Sponsor Collaborator
Hospital Sao Joao

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nocturnal noninvasive ventilation compliance per day 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. 9 months No
Secondary Health Economics Evaluation 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 9 months No
Secondary Health related Quality of Life Incremental gains in quality of life will be evalueted from a clinical perspective and as an investment. 9 months No
Secondary Arterial Blood Gases We aim to detect a 9 months No
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