Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Jul 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two ways to assess how well the diaphragm, the main muscle used for breathing, is working in babies and young children who need help with their breathing in the pediatric intensive care unit (PICU). The study aims to compare two methods: one that measures electrical activity in the diaphragm through the skin (called transcutaneous diaphragm electromyography or dEMG) and another that uses ultrasound (a type of imaging) to see the diaphragm's movements (called diaphragm ultrasound or dUS). By understanding how these two techniques relate to each other, researchers hope to improve the care of young patients with respiratory issues.

To be eligible for this study, babies up to 12 months old needing invasive breathing support may participate, provided they have met certain readiness criteria for coming off that support. Parents will need to give written consent for their child to join the study. The children participating will undergo tests using both dEMG and dUS to help researchers find out how well these methods work together. It's important to note that some children may not be eligible if they have specific medical conditions or are deemed too fragile by their doctor. This trial is currently recruiting participants at the Leiden University Medical Center.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 0 - 12 months of age at the moment of inclusion and born ≥ 37 weeks gestational age.
• * Specific patients cohort PICU:
• • pediatric patients with invasive respiratory support comply with the extubation readiness test (ERT) criteria
• • No spontaneous breathing for the duration of the assessment
• • Written parenteral informed consent (IC)
• • A patient can only participate once
• Exclusion Criteria:
• • Unilateral diaphragm paresis diagnosed by ultrasound
• • Congenital malformations not compatible with dEMG
• • Need of cardiac pacing
• • Congenital muscle atrophy disorder
• • Clinical instability requiring frequent interventions by the nursing staff that may interfere with the measurements
• • The attending physician considers the patient to be too vulnerable to participate in the study