NCT05027035 Diaphragm Paralysis: Surgery or Mechanical Ventialion
| NCT ID | NCT05027035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Diaphragm Paralysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-06-28 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Summary Rationale: The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. In patients with diaphragm paralysis the treatment (surgery versus non-invasive ventilation) is based on physician preference, not sound scientific evidence. Clearly studies are needed to guide a scientific decision making. Objective: In this pilot study the we want to know the clinical relevant effect of both therapies on EQ-5D\_5L, the latter being the primary outcome. Finally, it will show the investigators the costs of both therapies form a societal perspective. Study design: open-label, multi center intervention pilot study Study population: 20 participants \>18 year and diagnosed with a unilateral diaphragm paralysis resulting from phrenic nerve injury. Intervention: 10 participants for surgical plication and 10 participants for nocturnal non-invasive ventilation while on the wating list for surgical plication. Main study parameters/endpoints: The goal of the pilot study is to describe the effect of both plication and NIV on the endpoints of the intended efficiency study. The intended primary endpoint is quality of life as measured by the EQ-5D-5L questionnaire. Secondary endpoints are; the Medical Research Council (MRC) dyspnoea scale, the Diaphragmatic Paralysis Questionnaire, Borg dyspnoea score, 6 minute walk test, spirometry in both sitting and supine position, a polysomnography and transcutaneous measurement of carbon dioxide an oxygen saturation at night.
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.
Contact & Investigator
Peter Wijkstra, prof
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT05027035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diaphragm Paralysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05027035 currently recruiting?
Yes, NCT05027035 is actively recruiting participants. Contact the research team at p.j.wijkstra@umcg.nl for enrollment information.
Where is the NCT05027035 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT05027035 clinical trial?
NCT05027035 is sponsored by University Medical Center Groningen. The principal investigator is Peter Wijkstra, prof at University Medical Center Groningen. The trial plans to enroll 20 participants.