Actively Recruiting
Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
Led by Leiden University Medical Center · Updated on 2025-03-18
50
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background of the study: Increased work of breathing, potentially leading to respiratory insufficiency, resulting in the need of (non-) invasive respiratory support is the most common observed problem in the neonatal - and pediatric intensive care unit (NICU/PICU). The diaphragm is the main respiratory muscle. Currently there is not an established technique accessible to observe the (clinical) function of the diaphragm and its role in respiratory insufficiency. New non-invasive modalities are promising, such as transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS). Objective of the study: Our objective is to assess the association between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in the PICU population. Study design: Single center pilot study Study population: The study population consists of children between 0-12 months, admitted to the PICU of the Leiden University Medical Center, with invasive respiratory support. Primary study parameters/outcome of the study: Primary endpoint is to evaluate the association between dEMG and dUS measurements in the PICU population.
CONDITIONS
Official Title
Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 0 - 12 months of age at the moment of inclusion and born 63 37 weeks gestational age.
- Pediatric patients admitted to the PICU with invasive respiratory support who meet the extubation readiness test (ERT) criteria.
- No spontaneous breathing during the diaphragm function assessment.
- Written parental informed consent obtained.
- Each patient may participate only once.
You will not qualify if you...
- Unilateral diaphragm paresis diagnosed by ultrasound.
- Congenital malformations incompatible with transcutaneous diaphragm electromyography (dEMG).
- Requirement for cardiac pacing.
- Congenital muscle atrophy disorder.
- Clinical instability requiring frequent nursing interventions that could interfere with measurements.
- Attending physician considers the patient too vulnerable to participate in the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pediatric Intensive Care Unit
Leiden, Netherlands
Actively Recruiting
Research Team
S
Sabien Heisterkamp
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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