Diaphragm Paralysis: Surgery or Mechanical Ventialion

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Aug 24, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for patients with diaphragm paralysis, a condition where the diaphragm muscle, which helps you breathe, does not work properly. The trial will compare the effects of surgical plication (a procedure that tightens the diaphragm) and non-invasive ventilation (using a machine to help with breathing) on patients' quality of life. Researchers want to see how each treatment affects daily living and overall well-being, using a questionnaire and other assessments.

To participate in this study, you need to be over 18 years old and diagnosed with a unilateral diaphragm paralysis caused by an isolated injury to the phrenic nerve. This means you have breathing difficulties that worsen when lying down, and specific tests confirm your condition. If you join the study, you will be randomly assigned to either receive surgery or use a breathing machine at night while waiting for surgery. The trial is looking for a total of 20 participants, and it aims to gather important information that can help doctors make better treatment decisions for future patients.

Gender

ALL

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.