20 participants >18 year and diagnosed with a unilateral of bilateral diaphragm paralysis resulting from phrenic nerve injury.
Conditions
Interventions
Intervention: Surgical diaphragm-plication
Comparator: Non-invasive mechanical ventilation
Sponsors
ZonMw
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following 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: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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 |
|---|---|
| The primary question of the pilot study is whether a randomized trial comparing surgery versus non-invasive ventilation is feasible. In our opinion a randomized study is feasible if at least 50% of the participants fulfilling the inclusions criteria are randomized in this pilot study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The second goal of the pilot study is to describe the effect of both plication and NIV on the . primary endpoint being quality of life measured by the EQ-5D-5L questionnaire. 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. | — |
Contacts
Public ContactAnda Hazenberg
UMCG
Outcome results
None listed