Diaphragm Plication in Adults With Phrenic Nerve Paralysis

Study Overview
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Brief Summary
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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.

Official Title
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Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study

Conditions
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Phrenic Nerve Paralysis

Intervention / Treatment
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* Procedure: diaphragm plication 6 months after inclusion
* Procedure: diaphragm plication at time of inclusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uni- or bilateral diaphragmatic paralysis due to phrenic nerve paralysis present for at least 1 year With reduced VC, at least in supine position and no significant change in VC for at least 6 months At the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea Exclusion Criteria: No informed consent obtained Other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: COPD, parenchymal lung disease on the thoracic X-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,.... Abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease Known diseases resulting in abnormal blood coagulation Proven oncological origine of the phrenic nerve paralysis Age below 18 yrs old

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>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) | Procedure: diaphragm plication 6 months after inclusion<br>* thoracotomy<br>|
| Active Comparator: B<br>At time of inclusion the subject get the intervention | Procedure: diaphragm plication at time of inclusion<br>* thoracotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | Measurement of pulmonary function | 6 months after inclusion | 
| Pulmonary function | Measurement of pulmonary function | 12 months after inclusion | 
| Sleep | Polysomnography evaluation | 6 months after inclusion | 
| Sleep | Polysomnography evaluation | 12 months after inclusion |