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RECRUITING
NCT05965830

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

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Months - 12 Months

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2023-11-25

Completion Date

2025-11

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

DEVICE

Diaphragm ultrasound

A single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.

Locations (1)

Pediatric Intensive Care Unit

Leiden, Netherlands