Ultrasound as Diagnostic Tool in Diaphragm Dysfunction

Last updated: June 20, 2024
Sponsor: Isala
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

ultrasound of the diaphragm

Clinical Study ID

NCT05682027
Diaphragm 001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • Suspicion of diaphragm dysfunction based on medical history and/or physicalexamination; as determined by the treating physician.

Exclusion

Exclusion Criteria:

  • Inability for fluoroscopy (e.g. severely limited mobility, or unable to follow vocalinstructions).

  • Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to followvocal instructions).

  • Those not able or unwilling to give written informed consent.

  • Pregnant women

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: ultrasound of the diaphragm
Phase:
Study Start date:
September 05, 2023
Estimated Completion Date:
March 21, 2024

Study 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

Connect with a study center

  • Isala Klinieken

    Zwolle, Overijssel 8025AB
    Netherlands

    Site Not Available

  • UCMG

    Groningen, 9700RB
    Netherlands

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.