Ultrasound as Diagnostic Tool in Diaphragm Dysfunction (ULTRASONIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Diaphragm Disease
• Intervention / Treatment: Diagnostic test: ultrasound of the diaphragm

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

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700RB
    • UCMG
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025AB
      • Isala Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: ultrasound of the diaphragm; Parameters measured during ultrasound: Thickening fraction; End-expiratory thickness, and; Diaphragm excursion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of diaphragm paralysis as determined by ultrasound compared with the construct for diaphragm paralysis based on traditional measurements	Parameters: Paralysis (ultrasound): Qualitative (visual): Paradoxal movement OR Quantitative: Diaphragm Excursion(DE) < 0cm (negative).; Paralysis (reference): (Physical examination suggestive of diaphragm dysfunction (i.e. paradoxal abdominal movement) OR Decrease in vital capacity of >15% when suspine) AND Paradoxal movement during fluoroscopy.	From referall till completion of diagnostic tests.

Collaborators and Investigators

• Sponsor: Isala
• Investigators: Study Director: wytze de Boer, M.D., Isala

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): March 21, 2024
• Study Completion (Actual): March 21, 2024

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; diaphragm dysfunction; fluoroscopy
• Other Study ID Numbers: Diaphragm 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No