Actively Recruiting
Prospective Observational Study Comparing Diaphragm Electromyography and 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between two non-invasive ways to observe the diaphragm muscle function in infants and young children who need breathing support in the Pediatric Intensive Care Unit (PICU). The study focuses on children from birth up to 12 months old who are on invasive respiratory support and are ready for extubation. It aims to understand how diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) measurements relate to each other in this patient group. The study involves monitoring the diaphragm muscle using two techniques at the same time while the patient breathes spontaneously during the extubation readiness test. dEMG is recorded with three skin electrodes placed around the chest and sternum for 15 to 30 minutes. Ultrasound is performed by trained operators using specific probes to measure diaphragm movement and thickness during three different breaths. These measurements help assess the diaphragm's role in breathing. Participants will undergo simultaneous dEMG and ultrasound assessments while stable and breathing on their own. The study collects data on diaphragm muscle activity and structure to analyze their association. Researchers will measure and compare diaphragm electrical activity and ultrasound parameters over about one year. The study includes consent, and patients participate only once. Safety and clinical stability are monitored throughout the process.
CONDITIONS
Brief 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 and 12 months at the time of inclusion
- Born at or after 37 weeks gestational age
- Pediatric patients in PICU with invasive respiratory support who meet extubation readiness test criteria
- No spontaneous breathing during the assessment
- Written parental informed consent
- Each patient may participate only once
You will not qualify if you...
- Unilateral diaphragm paresis diagnosed by ultrasound
- Congenital malformations incompatible with diaphragm electromyography
- Need for cardiac pacing
- Congenital muscle atrophy disorder
- Clinical instability requiring frequent nursing interventions that may interfere with measurements
- Attending physician deems the patient too vulnerable to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment lasting up to 30 minutes
Participants undergo simultaneous monitoring of diaphragm muscle function using transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) during spontaneous breathing while meeting extubation readiness test criteria.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Pediatric Intensive Care Unit
Leiden, Netherlands
Actively Recruiting
Research Team
S
Sabien Heisterkamp
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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