Status:
RECRUITING
Diaphragm Paralysis: Surgery or Mechanical Ventialion
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Diaphragm Paralysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Summary Rationale: The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. In patients with diaphragm paralysis the treatment (surgery versus non-invasive ventilati...
Detailed Description
INTRODUCTION AND RATIONALE The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. It is the most important muscle of respiration innervated by the phrenic nerves....
Eligibility Criteria
Inclusion Criteria:
- >18 years
- diagnosed with a unilateral diaphragm paralysis based on isolated phrenic nerve injury.
Unilateral diaphragm paralysis is defined as follows: complaints of dyspnea and / or orthopnea combined with a drop in VC of more than 15% when change from upright to supine position and a positive sniff test during fluoroscopy or ultrasonography. A positive sniff test means that the diaphragm stands still or even moves in cranial direction (paradoxical movement ) during the sniff inspiratory maneuver.
- Ability to provide written consent
- Time between diagnosis and treatment should be at least 1 year
Exclusion Criteria:
- Patients diagnosed with a bilateral diaphragm paralysis.
- A diaphragm paralysis in combination with a more systemic neurological or neuromuscular disorder like for example Amyotrophic Lateral Sclerosis ,
- Hypercapnia during daytime (PaCO2 > 6.0 kPa)
- Radiotherapy of the thorax
- Contra indication for diaphragm surgery.
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05027035
Start Date
June 28 2024
End Date
June 1 2025
Last Update
December 11 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9700 RB