Ultrasound as Diagnostic Tool in Diaphragm Dysfunction

NCT05682027 | Completed DMC

• 1 other identifier: Diaphragm 001
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Diaphragm Disease

Keywords

diaphragm dysfunction; ultrasound; fluoroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

ultrasound of the diaphragm DIAGNOSTIC_TEST

Parameters measured during ultrasound: Thickening fraction; End-expiratory thickness, and; Diaphragm excursion.

Patients suspected of diaphragm dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead

Study Sites (2)

Isala Klinieken

Zwolle, Overijssel, 8025AB, Netherlands

Location

UCMG

Groningen, 9700RB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40187575 DERIVED

Study Officials

• wytze de Boer, M.D.

  Isala

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 12, 2023
• Study Start: September 5, 2023
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

NL (2)