Diaphragm; Paralysis clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT05027035 Recruiting - Diaphragm Paralysis Clinical Trials

Diaphragm Paralysis: Surgery or Mechanical Ventialion

PARASOL

Start date: June 28, 2024
Phase: N/A
Study type: Interventional

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.