Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study - Full Text View

Sponsored by:	Katholieke Universiteit Leuven
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00689234

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

MedlinePlus related topics: Exercise and Physical Fitness Paralysis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:

functional outcome measured by dyspnoe scores, pulmonary function tests, exercise capacity, sleep gas analysis [ Time Frame: within 6 months and 12 months after inclusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator 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
B: Active Comparator 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

Responsible Party:	Division of Pulmonology ( Bertien Buyse / Prof )
Study ID Numbers:	B32220083458 (no sponsor)
Study First Received:	May 30, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00689234
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Paralysis
Signs and Symptoms
Neurologic Manifestations

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009