Our objective is to assess the association between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in the PICU population.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is to evaluate the association between dEMG and dUS
measurements in the PICU population.
Secondary outcome
not applicable
Background summary
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).
Study objective
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 burden and risks
This study can only be performed within the infant and pediatric intensive care
population due the specific challenges seen in these patients as result of the
physiological immaturity of the respiratory system and immature lung
development in this specific population. As well the small size of the patients
with specific challenges of the precision of dEMG and dUS.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patients admitted at the pediatric intensive care unit
Age between 0 - 12 months of age at the moment of inclusion
Patients with invasive respiratory support that meet extubation readiness test
(ERT) criteria
A patient can only participate once
Exclusion criteria
- No spontaneous breathing for the duration of the assessment
- Unilateral diaphragm paresis
- Congenital malformations not compatible with transcutaneous EMG
- Congenital muscle atrophy disorder
- The attending physician considers the patient to be too vulnerable to
participate in the study
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83049.058.23 |