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| Name | Class |
|---|---|
| University of Twente | OTHER |
| Löwenstein BV | UNKNOWN |
| Vivisol | OTHER |
| Sencure BV |
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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.
Can be provided on request as the registry rules are no in Dutch
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients with Chronic Respiratory Failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive ventilation | Device | NIV as in standard care |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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COPD patients with chronic hypercapnic respiratory failure needing chronic NIV will be included
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marieke L Duiverman, MD PhD | Contact | 0031503613200 | m.l.duiverman@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marieke L Duiverman | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCG | Recruiting | Groningen | Netherlands |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| 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 |