Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Study Overview
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Brief Summary
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The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator. For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.

Detailed Description
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Can be provided on request as the registry rules are no in Dutch

Official Title
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Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Conditions
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Chronic Respiratory Failure, Non-invasive Ventilation

Intervention / Treatment
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* Device: Non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD patients indicated for chronic home NIV Exclusion Criteria: not able to read the written information and/or sign the informed consent form no possibility to perfrom measurements at home
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients with Chronic Respiratory Failure<br> | Device: Non-invasive ventilation<br>* NIV as in standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas exchange | Transcutaneous monitoring of gas exchange | baseline | 
| Gas exchange | Transcutaneous monitoring of gas exchange | 2 months | 
| Gas exchange | Transcutaneous monitoring of gas exchange | 4 months | 
| Gas exchange | Transcutaneous monitoring of gas exchange | 6 months | 
| Patient comfort | Patient comfort assessed by VAS scale | baseline | 
| Patient comfort | Patient comfort assessed by VAS scale | 2 months | 
| Patient comfort | Patient comfort assessed by VAS scale | 4 months | 
| Patient comfort | Patient comfort assessed by VAS scale | 6 months | 
| AECOPD | Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics) | 2 months, 4 months, 6 months | 
| AECOPD | Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics) | 2 months | 
| AECOPD | Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics) | 4 months | 
| Hospitalisations for AECOPD | Hospitalisations for acute exacerbations of COPD | 6 months | 
| Sleep quality | Sleep quality assessing sleep depth and sleep stages | 2 months | 
| Sleep quality | Sleep quality assessing sleep depth and sleep stages | 4 months | 
| Sleep quality | Sleep quality assessing sleep depth and sleep stages | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monitoring