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Diaphragm Plication in Adults With Phrenic Nerve Paralysis

Primary Purpose

Phrenic Nerve Paralysis

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

diaphragm plication 6 months after inclusion

diaphragm plication at time of inclusion

About this trial

This is an interventional treatment trial for Phrenic Nerve Paralysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospital Gasthuisberg Divisionof PulmonologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm 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)

At time of inclusion the subject get the intervention

Outcomes

Primary Outcome Measures

Dyspnea

Functional outcome measured by dyspnea score

Dyspnea

Functional outcome measured by dyspnea score

Exercise capacity

Functional outcome measured by exercise testing

Exercise capacity

Functional outcome measured by exercise testing

Secondary Outcome Measures

Pulmonary function

Measurement of pulmonary function

Pulmonary function

Measurement of pulmonary function

Sleep

Polysomnography evaluation

Sleep

Polysomnography evaluation

Full Information

NCT ID

NCT00689234

First Posted

May 30, 2008

Last Updated

August 5, 2013

Sponsor

KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT00689234

Brief Title

Diaphragm Plication in Adults With Phrenic Nerve Paralysis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phrenic Nerve Paralysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm 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)

Arm Title

Arm Type

Active Comparator

Arm Description

At time of inclusion the subject get the intervention

Intervention Type

Procedure

Intervention Name(s)

diaphragm plication 6 months after inclusion

Intervention Description

thoracotomy

Intervention Type

Procedure

Intervention Name(s)

diaphragm plication at time of inclusion

Intervention Description

thoracotomy

Primary Outcome Measure Information:

Title

Dyspnea

Description

Functional outcome measured by dyspnea score

Time Frame

6 months after inclusion

Title

Dyspnea

Description

Functional outcome measured by dyspnea score

Time Frame

12 months after inclusion

Title

Exercise capacity

Description

Functional outcome measured by exercise testing

Time Frame

6 months after inclusion

Title

Exercise capacity

Description

Functional outcome measured by exercise testing

Time Frame

12 months after inclusion

Secondary Outcome Measure Information:

Title

Pulmonary function

Description

Measurement of pulmonary function

Time Frame

6 months after inclusion

Title

Pulmonary function

Description

Measurement of pulmonary function

Time Frame

12 months after inclusion

Title

Sleep

Description

Polysomnography evaluation

Time Frame

6 months after inclusion

Title

Sleep

Description

Polysomnography evaluation

Time Frame

12 months after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bertien MA Buyse, MD,PhD

Phone

32 16 34 68 00

Bertien.Buyse@uz.kuleuven.ac.be

First Name & Middle Initial & Last Name or Official Title & Degree

Marc Decramer, MD,PhD

Phone

32 16 34 68 00

Marc.Decramer@uz.kuleuven.ac.be

Facility Information:

Facility Name

University Hospital Gasthuisberg Divisionof Pulmonology

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bertien MA Buyse, MD,Phd

Phone

32 16 34 68 00

Bertien.Buyse@uz.kuleuven.ac.be

First Name & Middle Initial & Last Name & Degree

Buyse MA Buyse, MD, PhD

12. IPD Sharing Statement

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Diaphragm Plication in Adults With Phrenic Nerve Paralysis

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