TELE-monitoring in Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

— TELECOPD  

Official title:

TELE-monitoring in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03129477
• Other study ID #: 1
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2018
• Source: Conde, Bebiana, M.D.
• Contact: Bebiana Conde, MD
• Phone: 00351936305294
• Email: bebianaconde[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Telemonitoring in noninvasive ventilation
Compare telemonitoring to conventional monitoring to optimize Ventilation

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Tras-os-Montes e Alto Douro	Vila Real

Sponsors (2)

Lead Sponsor	Collaborator
Conde, Bebiana, M.D.	ResMed

Country where clinical trial is conducted

Portugal, 

References & Publications (3)

Köhnlein T, Windisch W, Köhler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schönhofer B, Schucher B, Wegscheider K, Criée 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for appropriate adaptation and therapy efficacy	Calculate 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.	one year
Secondary	Rate of readmissions for COPD acute exacerbations and mortality	Calculate 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)	One year