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Management of childhood empyema: is there any abnormal lung-function after surgical intervention?


- candidate number2120
- NTR NumberNTR700
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2006
- Secondary IDs2006/110 METC
- Public TitleManagement of childhood empyema: is there any abnormal lung-function after surgical intervention?
- Scientific TitleManagement of childhood empyema: is there any abnormal lung-function after surgical intervention?
- ACRONYMLung-function after childhood empyema with surgical intervention
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jul-2006
- planned closingdate1-mei-2007
- Target number of participants60
- Interventions1 pulmonary function test and 1 excersice taking 4-5 hours of time.
- Primary outcomePrimary 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 outcomeSecundary 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 quotiŽnt (VCO2/VO2).
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf., MD., Dr. H.A. Heij
- CONTACT for SCIENTIFIC QUERIESProf., MD., Dr. H.A. Heij
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Funding not known yet
- PublicationsN/A
- Brief summaryThere 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.
- Main changes (audit trail)
- RECORD8-jun-2006 - 27-nov-2009


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