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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorLeiden University Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Age between 0 - 12 months of age at the moment of inclusion and born ≥ 37 weeks gestational age.

No spontaneous breathing for the duration of the assessment

Written parenteral informed consent (IC)

A patient can only participate once

Disqualifiers

Unilateral diaphragm paresis diagnosed by ultrasound

Congenital malformations not compatible with dEMG

Need of cardiac pacing

Congenital muscle atrophy disorder

Trial design

Treatments tested in this trial

  • Diaphragm ultrasound

Treatment groups

50 Participants
are divided into 1 treatment group