Comparing surgery and mechanical ventilation for diaphragm paralysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can FAPI or FDG PET/CT help diagnose active Peyronie's disease

  This study tests whether FAPI-PET/CT or FDG-PET/CT scans can detect active inflammation or fibroblast activity in men with Peyronie’s disease.

  Recruiting Phase 4 University Medical Center Groningen · Nieuwegein, Utrecht · NCT07903987

• PEM: a starting point to understand ME/CFS

  Researchers are studying post-exertional malaise to better understand ME/CFS in adults who report persistent fatigue and PEM.

  Recruiting University Medical Center Groningen · Groningen · NCT07715838

• Isoniazid inhalation in TB patients: a first-in-human look at local tolerability and body levels

  This early study tests inhaled isoniazid to see how well it tolerates the lungs and how it behaves in the body in adults with tuberculosis.

  Recruiting Phase 1 University Medical Center Groningen · Groningen · NCT07708779

• Neoadjuvant nivolumab for cervical cancer using tumor-draining lymph nodes

  This study tests different doses of nivolumab injected near the tumor to see if the treatment is safe and feasible before standard surgery in newly diagnosed cervical cancer.

  Recruiting Phase 1 University Medical Center Groningen · Groningen · NCT07653503

• Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

  This registry follows people with persistent, recurrent, or metastatic cervical cancer who are treated with pembrolizumab-containing regimens to see how well it works in real-world care.

  Recruiting at 3 sites Phase 4 University Medical Center Groningen · Amsterdam and 10 other locations · NCT07645625

• No Guts No Glory Probiotics: Can probiotics help with antipsychotic side effects?

  This study tests whether a probiotic supplement can help prevent weight gain, high blood sugar, and bad cholesterol in adults starting or already on antipsychotic medications.

  Recruiting at 3 sites Phase 2/3 University Medical Center Groningen · Leeuwarden, Provincie Friesland and 2 other locations · NCT07606014

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.