Status:
RECRUITING
Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
Lead Sponsor:
Leiden University Medical Center
Conditions:
Ultrasound
Transcutaneous EMG
Eligibility:
All Genders
Up to 12 years
Brief Summary
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 proble...
Detailed Description
All clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU with invasive respiratory support comply with the extubation readiness test (ERT) criteria are included ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05965830
Start Date
November 25 2023
End Date
November 1 2025
Last Update
March 18 2025
Active Locations (1)
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1
Pediatric Intensive Care Unit
Leiden, Netherlands