UltrasoundPROCEDURESNCT05965830
Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
An observational study of Ultrasound and Transcutaneous EMG, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Ultrasound, Transcutaneous EMG, Diaphragm
- What is being tested?
- Diaphragm ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Nov 2023to Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Pediatric Intensive Care Unit
Leiden
Sabien Heisterkamp, +3171529111, s.g.j.heisterkamp@lumc.nl
About this study
Official title: PRospective Observational Study Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With REspiratory Support: the PROCEDURES Study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Ultrasound, Transcutaneous EMG, Diaphragm, Neonate
- Being tested
- Diaphragm ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm ultrasoundDevice
Also called transcutaneous diaphragm EMG
A single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU. Receives: Device: Diaphragm ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Assessment of patient specific values of dEMG and dUS
To assess patient specific values of dEMG and dUS measurements in the PICU population while on spontaneous breathing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start25 Nov 2023
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sgjheisterkamp, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965830
- Sponsor's protocol ID
- P23-007
- Acronym
- PROCEDURES
- Status last verified
- Mar 2025
- First submitted
- 20 Jul 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided