Diaphragm DiseaseULTRASONICNCT05682027
Ultrasound as Diagnostic Tool in Diaphragm Dysfunction
An observational study of Diaphragm Disease, run by Isala at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Disease
- What is being tested?
- ultrasound of the diaphragm
- How many people
- 36 participants
- Where
- 2 sitesNetherlands
- Study dates
- 5 Sep 2023to 21 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years or older
- Suspicion of diaphragm dysfunction based on medical history and/or physical examination; as determined by the treating physician.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
UCMG
Groningen, 9700RB
Isala Klinieken
Zwolle, Overijssel, 8025AB
About this study
Official title: 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.
Read the 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
- Being tested
- ultrasound of the diaphragm
- Keywords
- diaphragm dysfunction, ultrasound, fluoroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound of the diaphragmDiagnostic test
Parameters measured during ultrasound:
Thickening fraction; End-expiratory thickness, and; Diaphragm excursion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ultrasound of the diaphragm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From referall till completion of diagnostic tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start5 Sep 2023
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wytze de Boer, Isala
- Investigators
- wytze de Boer, M.D., Study director, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682027
- Sponsor's protocol ID
- Diaphragm 001
- Acronym
- ULTRASONIC
- Status last verified
- Jun 2024
- First submitted
- 27 Dec 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40187575
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound as Diagnostic Tool in Diaphragm Dysfunction: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05682027
- Acronym / sponsor ID
- ULTRASONIC / Diaphragm 001
- Conditions
- Diaphragm Disease
- Keywords
- diaphragm dysfunction, ultrasound, fluoroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of diaphragm dysfunction | – | Diagnostic Test: ultrasound of the diaphragmAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 years or older
- Suspicion of diaphragm dysfunction based on medical history and/or physical examination; as determined by the treating physician.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound of the diaphragmParameters measured during ultrasound: Thickening fraction; End-expiratory thickness, and; Diaphragm excursion. | Diagnostic test | Patients suspected of diaphragm dysfunction |
Primary outcome
Concordance of diaphragm paralysis as determined by ultrasound compared with the construct for diaphragm paralysis based on traditional measurements
Time frame: From referall till completion of diagnostic tests.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 40187575de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wytze de Boer, M.D. study director
Isala
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Disease, run by Isala at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of diaphragm paralysis as determined by ultrasound compared with the construct for diaphragm paralysis based on traditional measurements (time frame: From referall till completion of diagnostic tests.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.