The primary objective of this study is to investigate the construct validity of ultrasound in diaphragm paralysis.
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concordance of diaphragm paralysis as determined by ultrasound compared with
the construct for diaphragm paralysis based on traditional measurements.
Secondary outcome
- Concordance of diaphragm paresis as determined by ultrasound compared with
the construct for diaphragm paresis based on traditional measurements.
- Inter-rater reproducibility of sonographic parameters.
- Feasibility of ultrasound for diaphragm imaging
- Differences in diagnostic sensitivity and specificity of ultrasound in
subpopulations with either unilateral or bilateral diaphragmatic dysfunction.
Background 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.
Study objective
The primary objective of this study is to investigate the construct validity of
ultrasound in diaphragm paralysis.
Study design
The study will be conducted as 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.
Study burden and risks
No risks or benefits are associated with participation of this study.
Fluoroscopy is part of regular care. Study measurements include ultrasound of
the diaphragm, which is non-invasive with an expected low burden for
participants.
dr. van Heesweg 2
Zwolle 8025AB
NL
dr. van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83628.075.23 |
| Other | volgt. |