Comparing diaphragm function measurement techniques in infants on respiratory support
PRospective Observational Study Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With REspiratory Support: the PROCEDURES Study
This study is testing two ways to measure how well the diaphragm works in infants on breathing support to see which method is more reliable for checking their readiness to breathe on their own.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 0 Months to 12 Months |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden) |
| Trial ID | NCT05965830 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in infants and children under 12 months receiving invasive respiratory support in the Pediatric Intensive Care Unit (PICU). The study will involve simultaneous monitoring of diaphragm function using both techniques during extubation readiness tests. Clinically stable patients who meet specific inclusion criteria will be enrolled, and measurements will be taken to assess diaphragm muscle function. The goal is to establish a reliable method for evaluating diaphragm performance in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are infants and children aged 0-12 months who are admitted to the PICU and require invasive respiratory support.
Not a fit: Patients with unilateral diaphragm paresis, congenital malformations, or those deemed too vulnerable by their physician may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment and management of respiratory insufficiency in neonates and children.
How similar studies have performed: While the use of dEMG and dUS is promising, this specific comparative approach in the PICU population is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leiden
- Pediatric Intensive Care Unit — Leiden, Netherlands (Recruiting)
Study contacts
- Study coordinator: Sabien Heisterkamp
- Email: s.g.j.heisterkamp@lumc.nl
- Phone: 003171529111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.