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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Observational Study Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With REspiratory Support: the PROCEDURES Study
- ClinicalTrials.gov ID
- NCT05965830
- Acronym / sponsor ID
- PROCEDURES / P23-007
- Conditions
- Ultrasound, Transcutaneous EMG, Diaphragm, Neonate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Device: Diaphragm ultrasoundThe study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU. |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm ultrasoundAlso: transcutaneous diaphragm EMGA single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing. | Device | Study cohort |
Primary outcome
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.
1 secondary outcome
Assessment of patient specific values of dEMG and dUS
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ultrasound
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Transcutaneous EMG, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabien Heisterkamp (003171529111, s.g.j.heisterkamp@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between dEMG amplitude and dUS diaphragm thickening fraction and dEMG tonic activity and diaphragm thickness (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.