Clinical trial NCT03129477: TELE-monitoring in Chronic Obstructive Pulmonary Disease
Official title: TELE-monitoring in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: Non invasive ventilation in COPD
Noninvasive ventilation
Tele-monitoring
Lead sponsor: Conde, Bebiana, M.D.
Sponsor class: INDIV
Collaborators: name: ResMed
First posted: 2017-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Time for appropriate adaptation and therapy efficacy
timeFrame: one year
Secondary outcomes:
measure: Rate of readmissions for COPD acute exacerbations and mortality
timeFrame: One year
Other outcomes:
Locations:
city: Vila Real
country: Portugal
facility: Centro Hospitalar Tras-os-Montes e Alto Douro
Study officials:
affiliation: Centro Hospitalar Tras-os-Montes e Alto Douro
name: Bebiana Conde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohnlein T, Windisch W, Kohler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schonhofer B, Schucher B, Wegscheider K, Criee CP, Welte T. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.
citation: Struik FM, Sprooten RT, Kerstjens HA, Bladder G, Zijnen M, Asin J, Cobben NA, Vonk JM, Wijkstra PJ. Nocturnal non-invasive ventilation in COPD patients with prolonged hypercapnia after ventilatory support for acute respiratory failure: a randomised, controlled, parallel-group study. Thorax. 2014 Sep;69(9):826-34. doi: 10.1136/thoraxjnl-2014-205126. Epub 2014 Apr 29.
citation: McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12.