TELE-monitoring in Chronic Obstructive Pulmonary Disease

NCT03129477 | Unknown

• 1 other identifier: 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of readmissions for COPD acute exacerbations and mortality

  One year

Study Arms (2)

Telemonitoring in NonInvasiveVentilation

EXPERIMENTAL

Tele-monitoring in noninvasive ventilation with Lumis 150 and others Resmed equipments with AirView monitoring system, in COPD patients. • Education and adaptation of the patient to NIV.

Procedure: Telemonitoring in noninvasive ventilation

2- conventional monitoring group

NO INTERVENTION

Conventional monitoring group • Education and adaptation of the patient to NIV.

Interventions

Telemonitoring in noninvasive ventilation PROCEDURE

Compare telemonitoring to conventional monitoring to optimize Ventilation

Telemonitoring in NonInvasiveVentilation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Conde, Bebiana, M.D.: lead
• ResMed: collaborator

Study Sites (1)

Centro Hospitalar Tras-os-Montes e Alto Douro

Vila Real, 5000, Portugal

Location

Related Publications (3)

• 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.

  PMID: 25066329 BACKGROUND

• 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.

  PMID: 24781217 BACKGROUND

• 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.

  PMID: 19213769 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Bebiana Conde, MD

  Centro Hospitalar Tras-os-Montes e Alto Douro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bebiana Conde, MD

CONTACT

00351936305294; bebianaconde@gmail.com

Bebiana Conde, MD

CONTACT

00351259300500

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Computorizada randomizados selection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2016
• First Posted: April 26, 2017
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 23, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

PT (1)