Diaphragm Plication in Adults With Phrenic Nerve Paralysis

• Sponsor: KU Leuven (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00689234
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 72
• Patients Per Site Per Month: 0.2

Study Details

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	Phase
Phrenic Nerve Paralysis	Procedure: diaphragm plication 6 months after inclusion; Procedure: diaphragm plication at time of inclusion	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 1, 2008
• Anticipated Primary Completion Date: Apr 1, 2014
• Anticipated Study Completion Date: Apr 1, 2014

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 [6 months after inclusion]

   Functional outcome measured by dyspnea score

2. Dyspnea [12 months after inclusion]

   Functional outcome measured by dyspnea score

3. Exercise capacity [6 months after inclusion]

   Functional outcome measured by exercise testing

4. Exercise capacity [12 months after inclusion]

   Functional outcome measured by exercise testing

Secondary Outcome Measures

1. Pulmonary function [6 months after inclusion]

   Measurement of pulmonary function

2. Pulmonary function [12 months after inclusion]

   Measurement of pulmonary function

3. Sleep [6 months after inclusion]

   Polysomnography evaluation

4. Sleep [12 months after inclusion]

   Polysomnography evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Gasthuisberg Divisionof Pulmonology	Leuven		Belgium	3000

Sponsors and Collaborators

• KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marc Decramer, Prof. Dr., KU Leuven
• ClinicalTrials.gov Identifier: NCT00689234
• Other Study ID Numbers: B32220083458 (no sponsor)
• First Posted: Jun 3, 2008
• Last Update Posted: Aug 7, 2013
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Paralysis

Study Results

No Results Posted as of Aug 7, 2013