Diaphragm Plication in Adults With Phrenic Nerve Paralysis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00689234

Enrollment

Registered

2008-06-03

Start date

2008-04-30

Completion date

2014-04-30

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phrenic Nerve Paralysis

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.

Interventions

PROCEDUREdiaphragm plication 6 months after inclusion

thoracotomy

PROCEDUREdiaphragm plication at time of inclusion

thoracotomy

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Exercise capacity	6 months after inclusion	Functional outcome measured by exercise testing
Dyspnea	6 months after inclusion	Functional outcome measured by dyspnea score

Secondary

Measure	Time frame	Description
Pulmonary function	6 months after inclusion	Measurement of pulmonary function
Sleep	6 months after inclusion	Polysomnography evaluation

Countries

Belgium

Contacts

Primary ContactBertien MA Buyse, MD,PhD

Bertien.Buyse@uz.kuleuven.ac.be32 16 34 68 00

Backup ContactMarc Decramer, MD,PhD

Marc.Decramer@uz.kuleuven.ac.be32 16 34 68 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026