Telemedicine and Ventilator Titration in Chronic Respiratory Patients Initiating Non-invasive Ventilation

Chronic Obstructive Pulmonary Disease Clinical Trial

— TeleMotiNIV  

Official title:

Randomized Trial Comparing Telemedicine Monitoring and Titration in Patients Initiating Non-invasive Ventilation With Usual Care (TELEMOTINIV Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01560741
• Other study ID #: TeleMotiNIV2012
• 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

Related Conditions & MeSH terms

• Chest Wall Disorders
• Chronic Obstructive Pulmonary Disease
• Hypoventilation
• Lung Diseases, Obstructive
• Neuromuscular Disease
• Neuromuscular Diseases
• Obesity Hypoventilation Syndrome
• Pulmonary Disease, Chronic Obstructive

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