Clinical trial NCT05682027: Ultrasound as Diagnostic Tool in Diaphragm Dysfunction
Official title: Ultrasound as Diagnostic Tool in Diaphragm Dysfunction: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Disease
Keywords: diaphragm dysfunction
ultrasound
fluoroscopy
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Suspicion of diaphragm dysfunction based on medical history and/or physical examination; as determined by the treating physician.

Exclusion Criteria:

* Inability for fluoroscopy (e.g. severely limited mobility, or unable to follow vocal instructions).
* Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions).
* Those not able or unwilling to give written informed consent.
* Pregnant women

Primary outcomes:
measure: Concordance of diaphragm paralysis as determined by ultrasound compared with the construct for diaphragm paralysis based on traditional measurements
timeFrame: From referall till completion of diagnostic tests.
Secondary outcomes:
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
city: Groningen
country: Netherlands
facility: UCMG
Study officials:
affiliation: Isala
name: wytze de Boer, M.D.
role: STUDY_DIRECTOR
References: