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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Obesity Hypoventilation Syndrome; Neuromuscular Disease; Chest Wall Disorders
• Intervention / Treatment: Device: Telemonitoring tools; Device: Usual Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: João Carlos Winck, PhD; Phone Number: 1567 +351 225 512 100; Email: jcwfc@hsjoao.min-saude.pt
• Study Contact Backup: Name: Miguel Gonçalves, PhD; Phone Number: 1567 +351 225 512 100; Email: goncalvesmr@gmail.com

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Recruiting
    • Hospital de S.João
    • Principal Investigator: João Carlos Winck, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Telemedicine Group; Patients will be initiated and adapted on non-invasive home mechanical ventilation in Pulmonology Department of S. João Hospital, in an outpatient setting, according to the prevailing standard of care for Chronic Respiratory Diseases patients in this unit. Patients will be provided with a ventilator outfitted with a wireless transmitter to allow the remote data collection of compliance and efficacy information. While patient sleeps, data is collected. If abnormalities criteria will be detected, remote titration of ventilator settings will be done to optimise therapy. Patient will be monitored again and data analyzed. This procedure will be repeated until we obtained the optimal ventilator parameters for each patient in this group. Nocturnal oximetry under home mechanical non-invasive ventilation will be carried out after one week and one month of treatment. Subjects also receive pre-arranged telephone calls to assist with progress.	Device: Telemonitoring tools; Patients will go home with telemedicine tools to monitor efficacy and compliance of non-invasive home mechanical ventilation; Other Names: wireless transmiter
Other: Usual care; Patients will be initiated and adapted on non-invasive home mechanical ventilation in Pulmonology Department of S. João Hospital, in an outpatient setting, according to the prevailing standard of care for Chronic Respiratory Diseases patients in this unit. Patients will be assessed by a hospital visit scheduled at the end of third month after their initial adaptation. In this hospital visit data provided by the ventilator will be transferred to research team computer so they could evaluate patient compliance and efficacy of ventilation criteria under the parameters used at home present at the time of assessment. If abnormality criteria will be detected, re-titration of ventilator settings will be made. Patients will be encouraged to call their respiratory consultant any time they had a problem or concern.	Device: 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.; Other Names: Hospital visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Health related Quality of Life	Incremental gains in quality of life will be evalueted from a clinical perspective and as an investment.	9 months
Arterial Blood Gases	We aim to detect a	9 months

Collaborators and Investigators

• Sponsor: Hospital Sao Joao
• Investigators: Principal Investigator: J C Winck, Phd, Hospital de S. João

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: March 20, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): October 4, 2012
• Last Update Submitted That Met QC Criteria: October 3, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Telemedicine; COPD; Chronic respiratory failure; Noninvasive Mechanical Ventilation; Home-care
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Obesity; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
• Other Study ID Numbers: TeleMotiNIV2012