Diaphragm Plication in Adults With Phrenic Nerve Paralysis
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 30, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedAugust 7, 2013
August 1, 2013
6 years
May 30, 2008
August 5, 2013
Conditions
Outcome Measures
Primary Outcomes (4)
Dyspnea
Functional outcome measured by dyspnea score
6 months after inclusion
Dyspnea
Functional outcome measured by dyspnea score
12 months after inclusion
Exercise capacity
Functional outcome measured by exercise testing
6 months after inclusion
Exercise capacity
Functional outcome measured by exercise testing
12 months after inclusion
Secondary Outcomes (4)
Pulmonary function
6 months after inclusion
Pulmonary function
12 months after inclusion
Sleep
6 months after inclusion
Sleep
12 months after inclusion
Study Arms (2)
A
PLACEBO COMPARATORAt 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)
B
ACTIVE COMPARATORAt time of inclusion the subject get the intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
University Hospital Gasthuisberg Divisionof Pulmonology
Leuven, 3000, Belgium
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
May 30, 2008
First Posted
June 3, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 7, 2013
Record last verified: 2013-08