Trial record 5 of 263 for:    Open Studies | "Paralysis"

Diaphragm Plication in Adults With Phrenic Nerve Paralysis

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014