MAIN QUESTIONIs there any difference in the lungfunction of those people, who have undergone surgical intervention since 1985 in relation to a childhood empyema, compared to the refence population?Which determinants caused a degraded pulmonary…
ID
Source
Brief title
Condition
- Pleural disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters of the pulmonary function test:
*Total lung capacity (TLC), FEV1/VC
Primary study parameter of the exersize test:
*VO2 max.
Secondary outcome
Secundary study parameters of the pulmonary function test:
*Forced vital capacity (FVC), FEV1, Maximal mid-expiratory flow (MMEF25*75%),
Residual volume (RV), diffusion capacity.
Secundary study parameters of the exersize test:
*heart frequenty max. (HF max.), max. exercise ventilation/max. voluntary
ventilation, max. tidal volume/inspiratorycapacity (Vt max/IC), O2 pulse, SO2,
respiratory quotiënt (VCO2/VO2).
Background summary
There is no consensus about the right treatment in childhood empyemas, which is
mostly a complication of bacterial pneumonia. Lots of studies have been done to
investigate the short term results of different treatments. Parameters were:
length of hospital stay, duration of symptoms, duration of oxygen supply, IC
admission, no. of drains etc. Because of the results, which aren't similar at
all, and the very low incidence of this childhood disease, there not enough
evidence to choose the right treatment. Long term results haven't been
investigated as well as the short term results, especially the long term
results of surgical intervention. This may be very important, because of the
low mortality of this disease, which means more long term complications, and
the lack of evidence in relation to the right treatment in short term studies.
This study will give us an overview of the lungfunctions of those people who
have had surgical treatment in relation to a childhood empyema in the last
twenty years.
Study objective
MAIN QUESTION
Is there any difference in the lungfunction of those people, who have undergone
surgical intervention since 1985 in relation to a childhood empyema, compared
to the refence population?
Which determinants caused a degraded pulmonary function?
Study design
It's a descriptive study to the lungfunction of those people, who were treated
by surgery for childhood empyema. They will be called upon to participate in a
pulmonary function test and an exercise test.
The study design has been created in such a way that it serves as a pilot-study
and eventually as part of a greater research study (i.e. a longitudinal
prospective study and/or a retrospective comparative study).
Study burden and risks
This study has a very low risk indication.
de Boelelaan 1117
1081 HV, Amsterdam
Nederland
de Boelelaan 1117
1081 HV, Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
The empyemas must suffice the next criteria: 'febrile illness with pulmonary dysfunction', 'accumulation of fluid in the pleural space on X-thorax or ultrasound' and 'purulent fluid in pleural space or signs of loculations on X-thorax or ultrasound/ WBC count * 15.000/*l.* Patients have undergone video assited thorocoscopic surgery, decortication or thoracotomy.
Exclusion criteria
Phase 1 empyemas; empyemas caused by trauma, surgery (other than interventional surgery) or tbc; mental retardation, age <6 years or chromosomal disease (cannot do pulmonary function testing); prematurity (<32 weeks), other lung diseases, such as cystic fibrosis, lung resections and asthma.
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 | NL11860.029.06 |