the PROCEDURES Study

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

Conditions
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Ultrasound, Transcutaneous EMG, Diaphragm, Neonate

Intervention / Treatment
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* Device: Diaphragm ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study cohort<br>The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU. | Device: Diaphragm ultrasound<br>* A single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.<br>* Other names: transcutaneous diaphragm EMG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint | to evaluate the association between dEMG and dUS measurements in the PICU population. | 1 year |