The objective of this study is to determine the ability of respiratory EMG measurements with a wearable to …
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
- Lower respiratory tract disorders (excl obstruction and infection)
- Respiratory tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>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.</p>
Secondary outcome
<p>Correlation between diaphragmatic EMG parameters during hospitalization and parameters that could indicate </p><p>respiratory distress:</p><ul><li>Respiratory rate</li><li>Sp02</li><li>Heart rate</li></ul>
Background summary
Monitoring of patients on pediatrie wards is currently performed by intermittent observations by nurses and/or doctors. However, a child's respiratory condition might deteriorate quickly and abruptly. lt 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 hospita! is safely possible, without unnecessarily prolonged admission. Electromyography (EMG) is used as an experimental tool to measure the activity of the diaphragm in pediatrie patients with respiratory disease. lt 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 pediatrie ward, alongside and not interfering with regular care.
Intervention
An adhesive patch will be applied to measure respiratory EMG.
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.
J. Roukema
Geert Grooteplein-zuid 10
Nijmegen 6525 GA
Netherlands
024-3655700
pediatricresearchunit@radboudumc.nl
J. Roukema
Geert Grooteplein-zuid 10
Nijmegen 6525 GA
Netherlands
024-3655700
pediatricresearchunit@radboudumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Admitted to pediatrie ward of one of the participating hospitals
- Aged 0 till 15
- One of the following (working) diagnoses at admission:
- Asthma
- Bronchiolitis
- BHR or viral wheeze
- Pneumonia
Exclusion criteria
Need for invasive ventilation
- Patient has ICD/pacemaker
- Parents and/or patient cannot understand Dutch
- lnformed consent trom bath parents (if applicable) cannot be obtained
- Skin where patch is positioned is damaged (e.g.. eczema)
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 |
| Research portal | NL-005460 |