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

NCT05965830 | Recruiting DMC

• 1 other identifier: P23-007
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ultrasound; Transcutaneous EMG; Diaphragm; Neonate

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Secondary Outcomes (1)

• Assessment of patient specific values of dEMG and dUS

  1 year

Study Arms (1)

Study cohort

The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU.

Device: Diaphragm ultrasound

Interventions

Diaphragm ultrasound DEVICE

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

Also known as: transcutaneous diaphragm EMG

Study cohort

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Pediatric Intensive Care Unit

Leiden, Netherlands

RECRUITING

Central Study Contacts

Sabien Heisterkamp

CONTACT

003171529111; s.g.j.heisterkamp@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric intensivist

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: November 25, 2023
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

NL (1)