No registrations found.
ID
Source
Brief title
Health condition
All the people, who have had an childhood empyema since 1985, will be included. The patients must have been admitted in the VU hospital or AMC hospital, which are both in Amsterdam, and they must have had a surgical operation, such as video assisted thoracoscopic surgery, decortication or thoracotomy. At the moment of follow up they have to be 6 years or older.
Sponsors and support
We will search for external funds, like the asthma fund.
Intervention
Outcome measures
Primary outcome
Primary study parameters of the pulmonary function test:
1. Total lung capacity (TLC);
2. FEV1/VC;
Primary study parameter of the exersize test:
3. VO2 max.
Secondary outcome
Secundary study parameters of the pulmonary function test:
1. Forced vital capacity (FVC);
2. FEV1;
3. Maximal mid-expiratory flow (MMEF25-75%);
4. Residual volume (RV);
5. Diffusion capacity.
Secundary study parameters of the exersize test:
6. Heart frequenty max. (HF max.);
7. Max. exercise ventilation/max. voluntary ventilation;
8. Max. tidal volume/inspiratorycapacity (Vt max/IC);
9. O2 pulse;
10. SO2;
11. 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
We expect that there will be a restrictive condition in the first place. After a longer period there may be an obstructive condition, due to the original infection. We expect that the leucocyte count of the pleural fluid, the number of loculations on ultrasound or CT scan and the per/postoperative complications at admission will predict a reduced pulmonary function.
Study design
N/A
Intervention
1 pulmonary function test and 1 excersice taking 4-5 hours of time.
P.O. Box 22660
H.A. Heij
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665693
h.a.heij@amc.uva.nl or ha.heij@vumc.nl
P.O. Box 22660
H.A. Heij
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665693
h.a.heij@amc.uva.nl or ha.heij@vumc.nl
Inclusion criteria
1. The childhood empyemas treated by surgery 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/microl;
2. Patients have undergone video assited thorocoscopic surgery, decortication or thoracotomy.
Exclusion criteria
1. Phase 1 empyemas;
2. Empyemas caused by trauma, surgery (other than interventional surgery) or tbc;
3. Mental retardation, age <6 years or chromosomal disease (cannot do pulmonary function testing);
4. 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 |
|---|---|
| NTR-new | NL640 |
| NTR-old | NTR700 |
| Other | METC : 2006/110 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |