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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Diaphragm ultrasound
DeviceA single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Study cohort1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary 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
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov