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NCT05027035: PARASOL
Diaphragm Paralysis: Surgery or Mechanical Ventialion
NA trial testing surgical plication" or "nocturnal non-invasive ventilation in Diaphragm Paralysis in 20 participants. Currently enrolling.
1 June 2025
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 20 |
| Start date | 28 June 2024 |
| Primary completion | 1 June 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- surgical plication" or "nocturnal non-invasive ventilation
Conditions studied
- Diaphragm Paralysis — all drugs for Diaphragm Paralysis →
Sponsor
University Medical Center Groningen
Who can join
18 and older, any sex, with Diaphragm Paralysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05027035
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05027035 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Center Groningen
- Last refreshed: 11 December 2024
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