Diaphragm PARAlysis : Surgery Or mechanicaL ventilation?

Completed

Conditions: Diaphragm paralysis

Registration Number: NL-OMON51915

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>The primary question is whether a randomized trial comparing surgery versus<br /><br>non-invasive ventilation is feasible. The study is feasible if at least 50% of<br /><br>the patients fulfilling the inclusion criteria are randomized in this pilot<br /><br>study </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are; the Medical Research Council (MRC) dyspnoea scale, the<br /><br>Diaphragmatic Paralysis Questionnaire, Borg dyspnoea score, Endurance Shuttle<br /><br>Walk Test (ESWT), spirometry in both sitting and supine position, a<br /><br>polysomnography and transcutaneous measurement of carbon dioxide an oxygen<br /><br>saturation at night.</p><br>