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Diaphragm Plication in Adults With Phrenic Nerve Paralysis

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ClinicalTrials.gov Identifier: NCT00689234
Recruitment Status : Unknown
Verified August 2013 by Marc Decramer, Katholieke Universiteit Leuven.
Recruitment status was:  Recruiting
First Posted : June 3, 2008
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Phrenic Nerve Paralysis Procedure: diaphragm plication 6 months after inclusion Procedure: diaphragm plication at time of inclusion

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study
Study Start Date : April 2008
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Dyspnea [ Time Frame: 6 months after inclusion ]
    Functional outcome measured by dyspnea score

  2. Dyspnea [ Time Frame: 12 months after inclusion ]
    Functional outcome measured by dyspnea score

  3. Exercise capacity [ Time Frame: 6 months after inclusion ]
    Functional outcome measured by exercise testing

  4. Exercise capacity [ Time Frame: 12 months after inclusion ]
    Functional outcome measured by exercise testing


Secondary Outcome Measures :
  1. Pulmonary function [ Time Frame: 6 months after inclusion ]
    Measurement of pulmonary function

  2. Pulmonary function [ Time Frame: 12 months after inclusion ]
    Measurement of pulmonary function

  3. Sleep [ Time Frame: 6 months after inclusion ]
    Polysomnography evaluation

  4. Sleep [ Time Frame: 12 months after inclusion ]
    Polysomnography evaluation


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Marc Decramer, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00689234     History of Changes
Other Study ID Numbers: B32220083458 (no sponsor)
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms