Comparing surgery and mechanical ventilation for diaphragm paralysis
Diaphragm Paralysis: Surgery or Mechanical Ventialion
This study is testing whether surgery or a breathing machine works better for adults with diaphragm paralysis caused by nerve injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05027035 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the clinical effects of two treatment approaches for unilateral diaphragm paralysis caused by phrenic nerve injury: surgical diaphragm plication and nocturnal non-invasive ventilation (NIV). The study will involve 20 participants over the age of 18, with half receiving surgical treatment and the other half using NIV while awaiting surgery. The primary outcome will be measured using the EQ-5D_5L scale, and the study will also assess the societal costs associated with both therapies. The goal is to provide evidence-based guidance for treatment decisions in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with unilateral diaphragm paralysis due to isolated phrenic nerve injury.
Not a fit: Patients with bilateral diaphragm paralysis or those with systemic neurological disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment for patients with diaphragm paralysis, potentially improving their quality of life.
How similar studies have performed: While there is limited evidence on this specific comparison, similar studies have explored treatment options for diaphragm paralysis, indicating a need for more rigorous evaluation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Peter Wijkstra, prof — University Medical Center Groningen
- Study coordinator: Peter Wijkstra, prof
- Email: p.j.wijkstra@umcg.nl
- Phone: +31 50 3613200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.