Overview
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.
Description
Inclusion criteria The study population consists of 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.
Sample size and time frame The required sample size is 50 patients in order to evaluate our primary objective. An interim analysis will be performed after inclusion of 30 patients. If sufficient data is obtained to answer the primary objective the study will be preliminary ended.
Study parameters Simultaneous monitoring of the diaphragm muscle function using dEMG and dUS will take place while the patient is on spontaneous breathing mode during ERT dEMG 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 with 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.
Eligibility
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