Diaphragm Plication in Adults With Phrenic Nerve Paralysis

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Phrenic Nerve Paralysis

Treatments: Procedure: diaphragm plication at time of inclusion; Procedure: diaphragm plication 6 months after inclusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00689234

B32220083458 (no sponsor)

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

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)

Treatment:

Procedure: diaphragm plication 6 months after inclusion

B

Active Comparator group

Description:

At time of inclusion the subject get the intervention

Treatment:

Procedure: diaphragm plication at time of inclusion