Trial record 5 of 241 for:    Open Studies | "Paralysis"

Diaphragm Plication in Adults With Phrenic Nerve Paralysis

This study is currently recruiting participants.
Verified August 2013 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00689234
First received: May 30, 2008
Last updated: August 5, 2013
Last verified: August 2013
  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: August 5, 2013
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 April 16, 2014