Diaphragm Plication in Adults With Phrenic Nerve Paralysis

Phrenic Nerve Paralysis Clinical Trial

Official title:

Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00689234
• Other study ID #: B32220083458 (no sponsor)
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2008
• Last updated: August 5, 2013
• Start date: April 2008
• Est. completion date: April 2014

Study information

• Verified date: August 2013
• Source: Katholieke Universiteit Leuven
• Contact: Bertien MA Buyse, MD,PhD
• Phone: 32 16 34 68 00
• Email: Bertien.Buyse[@]uz.kuleuven.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paralysis
• Phrenic Nerve Paralysis

Intervention

Procedure:
• diaphragm plication 6 months after inclusion
thoracotomy
• diaphragm plication at time of inclusion
thoracotomy

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg Divisionof Pulmonology	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea	Functional outcome measured by dyspnea score	6 months after inclusion	Yes
Primary	Dyspnea	Functional outcome measured by dyspnea score	12 months after inclusion	Yes
Primary	Exercise capacity	Functional outcome measured by exercise testing	6 months after inclusion	Yes
Primary	Exercise capacity	Functional outcome measured by exercise testing	12 months after inclusion	Yes
Secondary	Pulmonary function	Measurement of pulmonary function	6 months after inclusion	Yes
Secondary	Pulmonary function	Measurement of pulmonary function	12 months after inclusion	Yes
Secondary	Sleep	Polysomnography evaluation	6 months after inclusion	Yes
Secondary	Sleep	Polysomnography evaluation	12 months after inclusion	Yes