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

NCT01560741 | Unknown Phase 1

• 1 other identifier: TeleMotiNIV2012
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Neuromuscular Disease; Chest Wall Disorders; Obesity Hypoventilation Syndrome

Keywords

Chronic respiratory failure; Noninvasive Mechanical Ventilation; Home-care; Telemedicine; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Health Economics Evaluation

  9 months

• Health related Quality of Life

  9 months

• Arterial Blood Gases

  9 months

Study Arms (2)

Telemedicine Group

ACTIVE COMPARATOR

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

Usual care

OTHER

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

Interventions

Telemonitoring tools DEVICE

Patients will go home with telemedicine tools to monitor efficacy and compliance of non-invasive home mechanical ventilation

Also known as: wireless transmiter

Telemedicine Group

Usual Care DEVICE

The assessment of efficacy and compliance will be monitor at the end of third month. This is the date of the scheduled hospital visit.

Also known as: Hospital visit

Usual care

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• OHS:
• COPD
• NMD
• COPD:
• % 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

Sponsors & Collaborators

• Hospital Sao Joao: lead

Study Sites (1)

Hospital de S.João

Porto, Porto District, 4200-319, Portugal

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• J C Winck, Phd

  Hospital de S. João

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Carlos Winck, PhD

CONTACT

+351 225 512 100; jcwfc@hsjoao.min-saude.pt

Miguel Gonçalves, PhD

CONTACT

+351 225 512 100; goncalvesmr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

PT (1)