Diaphragm Plication in Adults With Phrenic Nerve Paralysis

Not Applicable

• Conditions: Phrenic Nerve Paralysis
• Interventions: Procedure: diaphragm plication 6 months after inclusion; Procedure: diaphragm plication at time of inclusion

• Registration Number: NCT00689234
• Lead Sponsor: KU Leuven

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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	diaphragm plication 6 months after inclusion	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	diaphragm plication at time of inclusion	At time of inclusion the subject get the intervention

Primary Outcome Measures

Name	Time	Method
Dyspnea	12 months after inclusion	Functional outcome measured by dyspnea score
Exercise capacity	12 months after inclusion	Functional outcome measured by exercise testing

Secondary Outcome Measures

Name	Time	Method
Pulmonary function	12 months after inclusion	Measurement of pulmonary function
Sleep	12 months after inclusion	Polysomnography evaluation

Trial Locations

Locations (1)

University Hospital Gasthuisberg Divisionof Pulmonology; 🇧🇪 Leuven, Belgium