Diaphragm Plication in Adults With Phrenic Nerve Paralysis
This study is currently recruiting participants.
Verified September 2012 by Katholieke Universiteit Leuven
Sponsor:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00689234
First received: May 30, 2008
Last updated: September 3, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Phrenic Nerve Paralysis |
Procedure: diaphragm plication 6 months after inclusion Procedure: diaphragm plication at time of inclusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study |
Resource links provided by NLM:
Further study details as provided by Katholieke Universiteit Leuven:
Primary Outcome Measures:
- Dyspnea [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: Yes ]Functional outcome measured by dyspnea score
- Dyspnea [ Time Frame: 12 months after inclusion ] [ Designated as safety issue: Yes ]Functional outcome measured by dyspnea score
- Exercise capacity [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: Yes ]Functional outcome measured by exercise testing
- Exercise capacity [ Time Frame: 12 months after inclusion ] [ Designated as safety issue: Yes ]Functional outcome measured by exercise testing
Secondary Outcome Measures:
- Pulmonary function [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: Yes ]Measurement of pulmonary function
- Pulmonary function [ Time Frame: 12 months after inclusion ] [ Designated as safety issue: Yes ]Measurement of pulmonary function
- Sleep [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: Yes ]Polysomnography evaluation
- Sleep [ Time Frame: 12 months after inclusion ] [ Designated as safety issue: Yes ]Polysomnography evaluation
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
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
thoracotomy
|
|
Active Comparator: B
At time of inclusion the subject get the intervention
|
Procedure: diaphragm plication at time of inclusion
thoracotomy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689234
Contacts
| Contact: Bertien MA Buyse, MD,PhD | 32 16 34 68 00 | Bertien.Buyse@uz.kuleuven.ac.be |
| Contact: Marc Decramer, MD,PhD | 32 16 34 68 00 | Marc.Decramer@uz.kuleuven.ac.be |
Locations
| Belgium | |
| University Hospital Gasthuisberg Divisionof Pulmonology | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Bertien MA Buyse, MD,Phd 32 16 34 68 00 Bertien.Buyse@uz.kuleuven.ac.be | |
| Principal Investigator: Buyse MA Buyse, MD, PhD | |
Sponsors and Collaborators
Katholieke Universiteit Leuven
More Information
No publications provided
| Responsible Party: | Marc Decramer, Prof. Dr., Katholieke Universiteit Leuven |
| ClinicalTrials.gov Identifier: | NCT00689234 History of Changes |
| Other Study ID Numbers: | B32220083458 (no sponsor) |
| Study First Received: | May 30, 2008 |
| Last Updated: | September 3, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013