Diaphragm paralysis Diaphragm paralysis
Conditions
Interventions
Surgical plication of the diaphragm
Mechanical Ventilation
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • >18 years • diagnosed with a unilateral or bilateral diaphragm paralysis based on isolated phrenic nerve injury. o 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint The primary question is whether a randomized trial comparing surgery versus non-invasive ventilation is feasible. The study is feasible if at least 50% of the patients fulfilling the inclusion criteria are randomized in this pilot study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are; the Medical Research Council (MRC) dyspnoea scale, the Diaphragmatic Paralysis Questionnaire, Borg dyspnoea score, Endurance Shuttle Walk Test (ESWT), spirometry in both sitting and supine position, a polysomnography and transcutaneous measurement of carbon dioxide an oxygen saturation at night. | — |
Countries
Netherlands
Outcome results
None listed