This study aims to validate the efficacy of a wireless and small EMG sensor as a tool for monitoring asthmatic children. We will analyse differences in diaphragmatic muscle activity as measured with this EMG sensor before and after administration of…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the difference between EMG-measured muscle activity of the
diaphragm before and after Salbutamol administration.
Secondary outcome
Secondary endpoints are:
• Correlation between the change in EMG-measured diaphragmatic muscle activity
and the change in CAS values in acute dyspnoeic children.
• Correlation between the change in EMG-measured diaphragmatic muscle activity
and the change in Borg values in acute dyspnoeic children.
• Correlation between the change in EMG-measured diaphragmatic muscle activity
and the change in FEV1 values in non-acute dyspnoeic children.
Background summary
Asthma is the most prevalent chronic diseases in children. Continuous
monitoring of symptoms is essential to reach good asthma control and to enable
a child with asthma to live a normal life, without exacerbations and with the
lowest possible medication dose. However, currently physicians lack tools to
objectively monitor disease activity in the intervals between hospital visits.
Electromyography (EMG) of the diaphragm is a promising technology to
objectively monitor dyspnoea in asthmatic children. A wireless and small EMG
sensor could be the first step towards availability of this technology for
children with asthma.
Study objective
This study aims to validate the efficacy of a wireless and small EMG sensor as
a tool for monitoring asthmatic children. We will analyse differences in
diaphragmatic muscle activity as measured with this EMG sensor before and after
administration of Salbutamol. We will also investigate correlations between
diaphragmatic muscle activity and Clinical Asthma Scores (CAS), Borg scores and
FEV1.
Study design
Two groups of children will be studied. The first group of children consists of
children aged 5-10 years, who have been diagnosed with asthma or are suspected
of having the disease. In this study, we will measure their diaphragmatic
muscle activity during a standard reversibility test using spirometry at the
outpatient clinic of one of the participating hospitals. Their diaphragmatic
muscle activity will be measured before, during and after the reversibility
testing and Salbutamol administration.
The second group consists of children aged 3-10 years with acute dyspnoea who
are treated with Salbutamol in the ER Unit of the Martini Hospital or of the
Beatrix Children*s hospital. During their stay at the ER Unit and (if
applicable) the first two days of their stay at the clinic, their diaphragmatic
muscle activity will be measured with the EMG sensor, and CAS and Borg scores
will be determined.
Neither the researchers nor the caregivers will be able to observe the EMG
measurements during the data collection, in order to ensure that care and
diagnostic procedures will not be influenced.
Study burden and risks
Participants will not be exposed to any substantial risk. The most important
burden is the application and removal of three adhesive electrodes on the
child*s skin. The removal might be slightly painful for children.
Hendrik Figeeweg 5L
Haarlem 2031BJ
NL
Hendrik Figeeweg 5L
Haarlem 2031BJ
NL
Listed location countries
Age
Inclusion criteria
a)
• Diagnosed or suspected with Asthma
• Having a reversibility test scheduled
• Age 5-10 yrs
b)
• Acute Dyspnea
• Treated with Salbutamol at the ER Unit
• Age 3-10 yrs
Exclusion criteria
• Congenital diseases that can cause dyspnea, i.e. severe congenital heart
defects or Cystic Fybrosis
• History of Herniated Diaphragm
• Allergy of EMG-electrodes
• Ex-prematures with a gestational age at birth <37 wks
• Pneumonia without signs of asthma or bronchial hyperresponsiveness
• Laryngitis subglottica
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76001.042.22 |