Skip to content

TELE-monitoring in Chronic Obstructive Pulmonary Disease

TELE-monitoring in Chronic Obstructive Pulmonary Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03129477
Acronym
TELECOPD
Enrollment
50
Registered
2017-04-26
Start date
2019-01-01
Completion date
2019-12-31
Last updated
2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

Non invasive ventilation in COPD, Noninvasive ventilation, Tele-monitoring

Brief summary

COPD is the fourth cause of death worldwide and it is expected to be the third in 2020. Non-invasive ventilation (NIV) has a positive impact in reducing mortality related to chronic respiratory failure in stable patients with COPD. Moreover, the addition of home NIV to home oxygen therapy reduces hospital admissions and improves patients outcomes. Patients monitoring is crucial. It is increasingly recognized the potential of telemedicine in reducing morbidity and mortality, as well as healthcare utilisation and its associated costs. In particular, home telemonitoring (TM)- a technology measuring patients'clinical parameters and symptoms at home and allowing communication between healthcare professionals and patients over distance- has gained much attention. However, despite a growing body of evidence for TM in the management of COPD and other chronic diseases, the benefit of telemonitoring for Home mechanical ventilation concerning clinical and economic outcomes remains to be clearly demonstrated. The study aims to assess the impact that telemonitoring would have NIV efficacy, patient quality of life and satisfaction, through a prospective randomized study.The primary endpoint is the time for appropriate adaptation and therapy efficacy, defined as average SatO2 to 90% in 24h oximetry.

Detailed description

A prospective randomized study, with 2 branches. The primary endpoint is the time for appropriate adaptation and therapy efficacy, defined as average SatO2 to 90% in 24h oximetry. Patients with COPD (n=100) based in Gold 2017. Patients with stable COPD and Pa CO2 \> 52 mmHg in blood gases. These patients might have a polygraph or polysomnographic sleep study AHI/RDI \< 15/h 1. 1st hospital visit - D0- Inclusion criteria Confirmation; Randomization to 2 groups (1 - telemonitoring group (TM group) with the equipment Lumis 150, Stellar 150 or ventilator Astral 150 with AirView system; 2 - conventional monitoring group (CM group); Mode and settings titration will be selected according to patients needs and tolerance; Education and adaptation of the patient to VNI and optimize ventilation. 2. 2nd home healthcare professionals visit (D 1M)- 3. 3th hospital visit- D 3M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis); Settings adjustment if required; 4. 4th hospital visit - D 6M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis) ; Settings adjustment if required 5. 5th hospital visit - D 12M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis); Settings adjustment if required

Interventions

PROCEDURETelemonitoring in noninvasive ventilation

Compare telemonitoring to conventional monitoring to optimize Ventilation

Sponsors

ResMed
CollaboratorINDUSTRY
Conde, Bebiana, M.D.
Lead SponsorINDIV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

Computorizada randomizados selection

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with COPD (n=100) based in Gold 2017. Patients with Stable COPD and PaCO2 \> 52 mmHg in blood gases. These patients might have a polygraph or polysomnographic sleep study AHI/RDI \<15/h

Exclusion criteria

* Patients with ventilatory treatment; * Without diagnosis of COPD * Polygraph or polysomnographic sleep study AHI/RDI \>=15/h

Design outcomes

Primary

MeasureTime frameDescription
Time for appropriate adaptation and therapy efficacyone yearCalculate the time required to achieve a 4-hour-day adherence on 70% of the days and a sato2 \<90% in less than 10% of the time in 24-hour oximetry.

Secondary

MeasureTime frameDescription
Rate of readmissions for COPD acute exacerbations and mortalityOne yearCalculate the hospital readmission rate by COPD acute exacerbations and mortality for 1 year and compare these rates between the 2 intervention groups (conventional monitoring and telemonitoring)

Countries

Portugal

Contacts

Primary ContactBebiana Conde, MD
bebianaconde@gmail.com00351936305294
Backup ContactBebiana Conde, MD
00351259300500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026