Diaphragm Paralysis: Surgery or Mechanical Ventialion (PARASOL)
Diaphragm Paralysis
About this trial
This is an interventional health services research trial for Diaphragm Paralysis focused on measuring mechanical ventilation, surgical plication of the diaphragm
Eligibility Criteria
Inclusion Criteria:
- >18 years
- diagnosed with a unilateral or bilateral diaphragm paralysis based on isolated phrenic nerve injury.
Unilateral or bilateral 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 unilateral or bilateral diaphragm paralysis due to 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.
Sites / Locations
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Surgical plication
Mechanical ventilation
Surgical plication of the diaphragm
Non-invasive ventiatilatory support