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NCT Number: NCT05965830

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

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.

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Key information

Conditions

Ultrasound Diaphragm Neonate Transcutaneous EMG

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Intensive Care Unit

Leiden, Netherlands

Location status: Recruiting

Location contact

Sabien Heisterkamp

CONTACT

[email protected]

+3171529111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diaphragm ultrasound

Device

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

Other names: transcutaneous diaphragm EMG

Primary outcomes

  1. Association between dEMG amplitude and dUS diaphragm thickening fraction and dEMG tonic activity and diaphragm thickness

    Time frame: 1 year

    Evaluation of the association between dEMG and dUS measurements in the PICU population with invasive respiratory support. Pearson's correlation coefficient is used to quantify the correlation between dEMG and dUS variables.

Secondary outcomes

  1. Assessment of patient specific values of dEMG and dUS

    Time frame: 1 year

    To assess patient specific values of dEMG and dUS measurements in the PICU population while on spontaneous breathing

Study contacts

Contact information is provided by the study sponsor or research team.

Sabien Heisterkamp

CONTACT

[email protected]

003171529111

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Acronym: PROCEDURES

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2023
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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