NCT05682027

Ultrasound as Diagnostic Tool in Diaphragm Dysfunction

Ultrasound as Diagnostic Tool in Diaphragm Dysfunction: a Prospective Observational Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Isala · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Diaphragm Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ultrasound of the diaphragm	Parameters measured during ultrasound: Thickening fraction; End-expiratory thickness, and; Diaphragm excursion.

Timeline

• Start date: 2023-09-05
• Primary completion: 2024-03-21
• Completion: 2024-03-21
• First posted: 2023-01-12
• Last updated: 2024-06-21

Locations

2 sites across 1 country: Netherlands