Status:
UNKNOWN
Diaphragm Plication in Adults With Phrenic Nerve Paralysis
Lead Sponsor:
KU Leuven
Conditions:
Phrenic Nerve Paralysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00689234
Start Date
April 1 2008
End Date
April 1 2014
Last Update
August 7 2013
Active Locations (1)
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1
University Hospital Gasthuisberg Divisionof Pulmonology
Leuven, Belgium, 3000