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The diaphragm is the main muscle for inspiration and vital for ventilation. Multiple diagnostic modalities can be performed in the work-up of suspected diaphragm dysfunction. Fluoroscopy has traditionally been the method of choice in diagnosing diaphragm paralysis and is still widely used in clinical practice, while alternative non-invasive and accessible methods have been available. Superiority of ultrasound over fluoroscopy for the diagnosis of diaphragm dysfunction has been suggested.
The primary objective of this study is to investigate the construct validity of ultrasound in diaphragm paralysis.
To study the sensitivity of ultrasound in diaphragm dysfunction we propose a prospective, operator-blinded, two-center, observational study. Participants will be evaluated for diaphragm dysfunction with fluoroscopy and pulmonary function testing as in standard of care. Additionally, ultrasound will be performed.
Construct validity The primary objective of this study is to investigate the construct validity of ultrasound in diaphragm paralysis. Validity is defined as the degree to which an instrument truly measure the construct(s) it purports to measure. In general, three different types of validity can be distinguished: content validity, criterion validity, and construct validity. Since evaluation with gold standard testing is invasive, as explained in the introduction, criterion validity testing not a feasible option. Therefore, in this study, we use construct validity to provide evidence of validity. Construct validity is defined as the degree to which the scores of an instrument (here: ultrasound) are consistent with scores of other instruments (here: pulmonary function tests, fluoroscopy). Construct validation is often considered less powerful, however, with strong theories and specific and challenging hypothesis, it is possible to acquire substantial evidence. Therefore, specific definitions of 'diaphragm paresis' and 'diaphragm paralysis' regarding diagnostic modalities are established in this protocol before the start of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients suspected of diaphragm dysfunction | After inclusion, participants will be evaluated for diaphragm dysfunction with fluoroscopy, as in standard of care. Additionally, during the same hospital visit ultrasound will be performed. The sonographer and the radiologist assessing the ultrasound and fluoroscopy, respectively, will be blinded to each other's' test results. Further assessment, and possible treatment, for diaphragm dysfunction is performed at the discretion of the treating physician. The primary outcome is the concordance of diaphragm paralysis as determined by ultrasound compared with the construct for diaphragm paralysis based on traditional measurements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound of the diaphragm | Diagnostic Test | Parameters measured during ultrasound: Thickening fraction; End-expiratory thickness, and; Diaphragm excursion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of diaphragm paralysis as determined by ultrasound compared with the construct for diaphragm paralysis based on traditional measurements | Parameters:
| From referall till completion of diagnostic tests. |
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Inclusion Criteria:
Exclusion Criteria:
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Our population consists of 18-years or older patients suspected of diaphragm dysfunction based on medical history and/or physical examination; as determined by the treating physician.
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| Name | Affiliation | Role |
|---|---|---|
| wytze de Boer, M.D. | Isala | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Klinieken | Zwolle | Overijssel | 8025AB | Netherlands | ||
| UCMG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40187575 | Derived | de Boer WS, Parlevliet KL, Kooistra LA, Koster D, Nieuwenhuis JA, Edens MA, van den Berg JWK, Boomsma MF, Stigt JA, Slebos DJ, Duiverman ML. Ultrasound as diagnostic tool in diaphragm dysfunction: a prospective construct validity study. Respir Med. 2025 May;241:108083. doi: 10.1016/j.rmed.2025.108083. Epub 2025 Apr 4. |
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| Groningen |
| 9700RB |
| Netherlands |