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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25528
Enrollment
60
Registered
2006-06-08
Start date
2006-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

1 pulmonary function test and 1 excersice taking 4-5 hours of time.

Sponsors

VU medical centre (Amsterdam); see scientific contact
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Contacts

Public ContactH.A. Heij

Academic Medical Center (AMC), Emma Children's Hospital and VU University Medical Center, Department of Pediatric Surgery (9d32), P.O. Box 22660

h.a.heij@amc.uva.nl or ha.heij@vumc.nl+31 (0)20 5665693

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)