Phrenic Nerve ParalysisNCT00689234
Diaphragm Plication in Adults With Phrenic Nerve Paralysis
A study testing diaphragm plication 6 months after inclusion and diaphragm plication at time of inclusion in people with Phrenic Nerve Paralysis, run by KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phrenic Nerve Paralysis
- What is being tested?
- diaphragm plication 6 months after inclusion and diaphragm plication at time of inclusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2008to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Gasthuisberg Divisionof Pulmonology
Leuven, 3000
Bertien MA Buyse, MD,Phd, 32 16 34 68 00, Bertien.Buyse@uz.kuleuven.ac.be
Buyse MA Buyse, MD, PhD
About this study
Official title: 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.
- Conditions
- Phrenic Nerve Paralysis
- Being tested
- diaphragm plication 6 months after inclusion, diaphragm plication at time of inclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm plication 6 months after inclusionProcedure or surgery
thoracotomy
diaphragm plication at time of inclusionProcedure or surgery
thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | 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) Receives: Procedure: diaphragm plication 6 months after inclusion |
| B | Active comparator | At time of inclusion the subject get the intervention Receives: Procedure: diaphragm plication at time of inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Functional outcome measured by dyspnea score
Measured: 6 months after inclusion
Dyspnea
Functional outcome measured by dyspnea score
Measured: 12 months after inclusion
Exercise capacity
Functional outcome measured by exercise testing
Measured: 6 months after inclusion
Exercise capacity
Functional outcome measured by exercise testing
Measured: 12 months after inclusion
Secondary outcomes (4)
Pulmonary function
Measurement of pulmonary function
Measured: 6 months after inclusion
Pulmonary function
Measurement of pulmonary function
Measured: 12 months after inclusion
Sleep
Polysomnography evaluation
Measured: 6 months after inclusion
Sleep
Polysomnography evaluation
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phrenic Nerve ParalysisStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Decramer, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689234
- Sponsor's protocol ID
- B32220083458 (no sponsor)
- Status last verified
- Aug 2013
- First submitted
- 30 May 2008
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT00689234
- Acronym / sponsor ID
- B32220083458 (no sponsor)
- Conditions
- Phrenic Nerve Paralysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Procedure: diaphragm plication 6 months after inclusionAt 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 comparator | Procedure: diaphragm plication at time of inclusionAt time of inclusion the subject get the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diaphragm plication 6 months after inclusionthoracotomy | Procedure or surgery | A |
| diaphragm plication at time of inclusionthoracotomy | Procedure or surgery | B |
Primary outcome
Dyspnea
Time frame: 6 months after inclusion
Functional outcome measured by dyspnea score
Dyspnea
Time frame: 12 months after inclusion
Functional outcome measured by dyspnea score
Exercise capacity
Time frame: 6 months after inclusion
Functional outcome measured by exercise testing
Exercise capacity
Time frame: 12 months after inclusion
Functional outcome measured by exercise testing
4 secondary outcomes
Pulmonary function
Time frame: 6 months after inclusion
Pulmonary function
Time frame: 12 months after inclusion
Sleep
Time frame: 6 months after inclusion
Sleep
Time frame: 12 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Related trials for Phrenic Nerve Paralysis
Not yet recruitingPhase 4
Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery
Hemidiaphragmatic Paralysis, Postoperative Pain
Recruiting
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
Atrial Fibrillation
Not yet recruiting
Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries
Spinal Cord Injuries (SCI), Sleep Disordered Breathing (SDB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragm plication 6 months after inclusion and diaphragm plication at time of inclusion in people with Phrenic Nerve Paralysis, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertien MA Buyse, MD,PhD (32 16 34 68 00, Bertien.Buyse@uz.kuleuven.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: 6 months after inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.