In the present study we want to examine the effect of salbutamol on the muscle tone of the diaphragm. We also want to examine the correlation between muscle tension measured by EMG and the Clinical Asthma Score. To include the children that come to…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main data obtained in this study are the EMG values **before and after
treatment with Salbutamol in children with acute dyspnea.
Secondary outcome
Secondary outcome measure is the degree of dyspnea. This consists of the
Clinical Asthma Score, determined by the investigator, and the Borg scale,
determined by the parents. Beside, EMG values **of acutely distressed children
will be compared with EMG values **in healthy peers.
Background summary
Acute dyspnea is common in children younger than 6 years. In this age there are
currently few reliable measurement tools to objectively determine. The degree
of dyspnea in children with acute dyspnea is often on clinical grounds. In
children with acute dyspnea usually started with a trial treatment with
salbutamol. In young children it is difficult to objectively determine whether
and how large the effect of salbutamol is. Previous research has shown that
measuring muscle tone through EMG of the intercostal muscles and diaphragm is
feasible in children younger than 6 years. Also the EMG measurements correlated
strongly with the values found with the subjective Clinical Asthma Score. This
study, however, is done with only a small group of children.
Study objective
In the present study we want to examine the effect of salbutamol on the muscle
tone of the diaphragm. We also want to examine the correlation between muscle
tension measured by EMG and the Clinical Asthma Score. To include the children
that come to the emergency ward with acute distress, but will not be
hospitalized, we also want to measure the muscle tone of the diaphragm in
healthy peers, so we have a suitable controle measurement for these children.
Study design
The study is a prospective study. In children who come in the emergency
department because of dyspnea will be measured EMG values before and after
treatment with Salbutamol. If these children are hospitalized they will be
measured on the first three days of hospitalization and on the day of
dismissal. With a shorter hospital stay, the remaining measurements canceled
and the last measurement will be seen as the measurement for dismissal. In
addition, the Clinical Asthma Score is determined and a parent will be asked to
indicate on a scale of 1 to 10 the dyspnea of the child. Finally, the parents
will be asked to complete a questionnaire. The questionnaire focuses on the
history of the child, exposure to tobacco smoke, asthma symptoms and preventing
asthma in the family.
The EMG measurements in the control group will take place at the nursery, after
school care or school of the child, after obtaining permission from the
parents. This will be a single measurement, wherein no Salbutamol will be
administered. Finally, these parents will be asked to complete a questionnaire.
Study burden and risks
The EMG measurements as will be performed in this study are painless and
minimally stressful. The child will be asked a few moments to lie still.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Research group:
- Children from 0 months to 6 years who present with acute shortness of breath and treated with Sabutamol (sometimes combined with Ipratropium bromide). ;control group:
- Children from 0 months to 6 years
- From a nursery, after school care or school in the province of Groningen and Drenthe
Exclusion criteria
research group:
- Congenital disorders that can cause distress and severe congenital heart disease or cystic fibrosis.
- Status after diaphragmatic hernia
- Allergy to EMG patches
- Prematurity
- Pneumonia ;control group:
- Congenital disorders or acquired diseases that can cause distress and severe congenital heart defects, cystic fibrosis, asthma, pneumonia.
- Use of bronchodilator agents
- Status after diaphragmatic hernia
- Allergy to EMG patches
- Prematurity
Design
Recruitment
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 | NL46269.042.13 |