NCT05965830

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

PRospective Observational Study Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With REspiratory Support: the PROCEDURES Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 0 Months – 12 Months
• Healthy volunteers: Not accepted

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 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.

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 after informed consent. After inclusion simultaneous monitoring of the diaphragm muscle function using transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) will take place while the patient is on spontaneous breathing mode during ERT. Transcutaneous diaphragm electromyography measurements are performed using three skin electrodes; two electrodes are bilaterally placed at the costo-abdominal margin in the nipple line and one at or above the sternum during a time period of 15 minutes, with a maximum of 30 minutes. Ultrasound examination is performed using a linear transducer, and micro-convex transducer by trained operators. The views are achieved with the patient in supine position. Diaphragm excursion (DE), diaphragm thickness (DT) and diaphragm thickening fraction (DTF) are measured, performed at three different breathing cycles within one examination event. After completion of the measurements analysis will be performed to evaluate the association between dEMG and dUS outcomes in this specific PICU population.

Conditions

• Ultrasound
• Transcutaneous EMG
• Diaphragm
• Neonate

Interventions

Type	Name	Description
DEVICE	Diaphragm ultrasound	A single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.

Timeline

• Start date: 2023-11-25
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2023-07-28
• Last updated: 2025-03-18

Locations

1 site across 1 country: Netherlands