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Status unknownNCT00689234Updated Aug 7, 2013

Diaphragm Plication in Adults With Phrenic Nerve Paralysis

An interventional study of diaphragm plication 6 months after inclusion and diaphragm plication at time of inclusion in Phrenic Nerve Paralysis, sponsored by KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by KU Leuven · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Phrenic Nerve Paralysis

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03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's planned enrollment of 12 is below the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • 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

  • Active comparator
    B

    At time of inclusion the subject get the intervention

    Procedure: diaphragm plication at time of inclusion

Interventions

  • Procedurediaphragm plication 6 months after inclusion

    thoracotomy

  • Procedurediaphragm plication at time of inclusion

    thoracotomy

06

What researchers measure

Primary outcomes

  1. Dyspnea

    Functional outcome measured by dyspnea score

    Time frame: 6 months after inclusion

  2. Dyspnea

    Functional outcome measured by dyspnea score

    Time frame: 12 months after inclusion

  3. Exercise capacity

    Functional outcome measured by exercise testing

    Time frame: 6 months after inclusion

  4. Exercise capacity

    Functional outcome measured by exercise testing

    Time frame: 12 months after inclusion

Secondary outcomes

  1. Pulmonary function

    Measurement of pulmonary function

    Time frame: 6 months after inclusion

  2. Pulmonary function

    Measurement of pulmonary function

    Time frame: 12 months after inclusion

  3. Sleep

    Polysomnography evaluation

    Time frame: 6 months after inclusion

  4. Sleep

    Polysomnography evaluation

    Time frame: 12 months after inclusion

07

Study locations

1 of 1 sites recruiting
  • University Hospital Gasthuisberg Divisionof Pulmonology
    Leuven, 3000, Belgium
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00689234
Lead sponsor
KU Leuven
Responsible party
Marc Decramer (Prof. Dr., KU Leuven) — Principal investigator
First posted
Jun 3, 2008
Start date
Apr 2008
Primary completion
Apr 2014 (estimated)
Completion
Apr 2014 (estimated)
Last update
Aug 7, 2013

Study contacts

Bertien MA Buyse, MD,PhD
Contact
Bertien.Buyse@uz.kuleuven.ac.be
32 16 34 68 00
Marc Decramer, MD,PhD
Contact
Marc.Decramer@uz.kuleuven.ac.be
32 16 34 68 00

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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