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The purpose of the study is to investigate the impact of unilateral or bilateral diaphragm plication in a prospective randomised controlled way on symptoms, pulmonary function including gas exchange, respiratory muscle strength, exercise capacity and breathing during sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least 1 year without any evidence of spontaneous recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | At time of inclusion randomised in the "no intervention" arm (the subjects will be re-evaluated 6 months later and will get intervention at that time (cross-over protocol) |
|
| B | Active Comparator | At time of inclusion the subject get the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diaphragm plication 6 months after inclusion | Procedure | thoracotomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | Functional outcome measured by dyspnea score | 6 months after inclusion |
| Dyspnea | Functional outcome measured by dyspnea score | 12 months after inclusion |
| Exercise capacity | Functional outcome measured by exercise testing | 6 months after inclusion |
| Exercise capacity | Functional outcome measured by exercise testing | 12 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function | Measurement of pulmonary function | 6 months after inclusion |
| Pulmonary function | Measurement of pulmonary function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertien MA Buyse, MD,PhD | Contact | 32 16 34 68 00 | Bertien.Buyse@uz.kuleuven.ac.be | |
| Marc Decramer, MD,PhD | Contact | 32 16 34 68 00 | Marc.Decramer@uz.kuleuven.ac.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gasthuisberg Divisionof Pulmonology | Recruiting | Leuven | 3000 | Belgium |
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| diaphragm plication at time of inclusion |
| Procedure |
thoracotomy |
|
| 12 months after inclusion |
| Sleep | Polysomnography evaluation | 6 months after inclusion |
| Sleep | Polysomnography evaluation | 12 months after inclusion |