- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00689234
Diaphragm Plication in Adults With Phrenic Nerve Paralysis
August 5, 2013 updated by: Marc Decramer, KU Leuven
Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bertien MA Buyse, MD,Phd
- Phone Number: 32 16 34 68 00
- Email: Bertien.Buyse@uz.kuleuven.ac.be
Study Contact Backup
- Name: Marc Decramer, MD,PhD
- Phone Number: 32 16 34 68 00
- Email: Marc.Decramer@uz.kuleuven.ac.be
Study Locations
-
-
-
Leuven, Belgium, 3000
- Recruiting
- University Hospital Gasthuisberg Divisionof Pulmonology
-
Contact:
- Bertien MA Buyse, MD,Phd
- Phone Number: 32 16 34 68 00
- Email: Bertien.Buyse@uz.kuleuven.ac.be
-
Principal Investigator:
- Buyse MA Buyse, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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)
|
thoracotomy
|
ACTIVE_COMPARATOR: B
At time of inclusion the subject get the intervention
|
thoracotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: 6 months after inclusion
|
Functional outcome measured by dyspnea score
|
6 months after inclusion
|
Dyspnea
Time Frame: 12 months after inclusion
|
Functional outcome measured by dyspnea score
|
12 months after inclusion
|
Exercise capacity
Time Frame: 6 months after inclusion
|
Functional outcome measured by exercise testing
|
6 months after inclusion
|
Exercise capacity
Time Frame: 12 months after inclusion
|
Functional outcome measured by exercise testing
|
12 months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary function
Time Frame: 6 months after inclusion
|
Measurement of pulmonary function
|
6 months after inclusion
|
Pulmonary function
Time Frame: 12 months after inclusion
|
Measurement of pulmonary function
|
12 months after inclusion
|
Sleep
Time Frame: 6 months after inclusion
|
Polysomnography evaluation
|
6 months after inclusion
|
Sleep
Time Frame: 12 months after inclusion
|
Polysomnography evaluation
|
12 months after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (ANTICIPATED)
April 1, 2014
Study Completion (ANTICIPATED)
April 1, 2014
Study Registration Dates
First Submitted
May 30, 2008
First Submitted That Met QC Criteria
June 2, 2008
First Posted (ESTIMATE)
June 3, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
August 7, 2013
Last Update Submitted That Met QC Criteria
August 5, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B32220083458 (no sponsor)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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