The objective of this study is to determine the ability of respiratory EMG measurements with a wearable to correlate respiratoryimprovement or deterioration in hospitalised children with respiratory disease.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the correlation between changes in diaphragmatic EMG
parameters during hospitalisation and
changes in treatment, i.e. step-up or step-down in treatment.
Secondary outcome
Correlation between diaphragmatic EMG parameters during hospitalization and
parameters that could indicate respiratory distress:
• Respiratory rate
• SpO2
• Heart rate
Background summary
Monitoring of patients on pediatric wards is currently performed by
intermittent observations by nurses and/or doctors. However, a
child*s respiratory condition might deteriorate quickly and abruptly. It is
difficult to predict clinical deterioration, even for the most
skilled and experienced health care providers. On the other hand, clinical
improvement during admission for respiratory disease
will also be assessed during intermittent observations. Typically, children
will only be discharged when respiratory support is
stopped and a clinically stable condition has been observed for some time,
including a period of sleep to observe vital parameters
(e.g. oxygen saturation). Predicting clinical recovery could assist healthcare
providers to decide whether discharge from hospital is
safely possible, without unnecessarily prolonged admission. Electromyography
(EMG) is used as an experimental tool to measure
the activity of the diaphragm in pediatric patients with respiratory disease.
It could provide an easy, passive method to monitor
respiration in the hospital.
Study objective
The objective of this study is to determine the ability of respiratory EMG
measurements with a wearable to correlate respiratory
improvement or deterioration in hospitalised children with respiratory disease.
Study design
The study will have an exploratory design.
An adhesive patch will be applied to measure respiratory EMG. This measurement
will be performed during the admittance of the
subject to the pediatric ward, alongside and not interfering with regular care.
Study burden and risks
The study provides no risks to subjects. The measurements will be performed
alongside regular care according to current
guidelines. There is no additional burden involved in this study.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
• Admitted to pediatric ward of one of the participating hospitals
• Aged 0 till 15
• One of the following (working) diagnoses at admission:
o Asthma
o Bronchiolitis
o BHR or viral wheeze
o Pneumonia
Exclusion criteria
• Admittance to the ICU
• Patient has ICD/pacemaker
• Parents and/or patient cannot understand Dutch
• Informed consent from both parents (if applicable) cannot be obtained
• Skin where patch is positioned is damaged (e.g.. eczema)
Design
Recruitment
Medical products/devices used
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 | NL87160.091.24 |