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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01560741
Recruitment Status : Unknown
Verified October 2012 by Miguel R. Goncalves, Hospital Sao Joao.
Recruitment status was:  Recruiting
First Posted : March 22, 2012
Last Update Posted : October 4, 2012
Information provided by (Responsible Party):
Miguel R. Goncalves, Hospital Sao Joao

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Neuromuscular Disease Chest Wall Disorders Obesity Hypoventilation Syndrome Device: Telemonitoring tools Device: Usual Care Phase 1

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  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Telemedicine Monitoring and Titration in Patients Initiating Non-invasive Ventilation With Usual Care (TELEMOTINIV Study)
Study Start Date : July 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

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 Name: wireless transmiter

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 Name: Hospital visit

Primary Outcome Measures :
  1. Nocturnal noninvasive ventilation compliance per day [ Time Frame: 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 Outcome Measures :
  1. Health Economics Evaluation [ Time Frame: 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

  2. Health related Quality of Life [ Time Frame: 9 months ]
    Incremental gains in quality of life will be evalueted from a clinical perspective and as an investment.

  3. Arterial Blood Gases [ Time Frame: 9 months ]
    We aim to detect a

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • PaCO2 > 45 mmHg;
  • IMC > 40 Kg/m2


  • 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:


  • COPD
  • NMD


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01560741

Contact: João Carlos Winck, PhD +351 225 512 100 ext 1567
Contact: Miguel Gonçalves, PhD +351 225 512 100 ext 1567

Hospital de S.João Recruiting
Porto, Portugal, 4200-319
Principal Investigator: João Carlos Winck, PhD         
Sponsors and Collaborators
Hospital Sao Joao
Principal Investigator: J C Winck, Phd Hospital de S. João

Responsible Party: Miguel R. Goncalves, Clinical Professor, Hospital Sao Joao Identifier: NCT01560741     History of Changes
Other Study ID Numbers: TeleMotiNIV2012
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Miguel R. Goncalves, Hospital Sao Joao:
Chronic respiratory failure
Noninvasive Mechanical Ventilation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Neuromuscular Diseases
Obesity Hypoventilation Syndrome
Respiratory Tract Diseases
Nervous System Diseases
Respiratory Insufficiency
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nutrition Disorders