Empyema, Pleural
Conditions
Brief summary
Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial. The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.
Interventions
Other interventions except drainage procedure are the same in both arms
Sponsors
Queen Fabiola Children's University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* patients under the age of 17 * pleural fluid depth of at least 15mm, confirmed by ultrasound * at least one of the following severity criteria : 1. fever continuing 48h after starting correct antibiotherapy 2. respiratory distress 3. mediastinal displacement on the chest X-ray
Exclusion criteria
* previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment * congenital pulmonary disorders with lung function impairment * chronic pulmonary disease associated with lung function impairment * hemodynamic instability * congenital immunodeficiency disease * secondary immune deficiency induced * hemostasis disorder (contraindication of thrombolytic therapy) * pregnancy or breastfeeding patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of drainage | end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days |
Secondary
| Measure | Time frame |
|---|---|
| Duration of oxygen therapy | up to the end of patient hospitalisation with an expected average time of 48 hours to five days |
| duration of intravenous antibiotic therapy | up to the last intravenous antibiotic injection, minimum of 48 hours for a simple pleural effusion and a minimum of 14 days for an empyema with a maximum of one month |
| length of hospital stay | Hospital departure with an expected average time of two weeks to one month |
| Number of Participants with Serious and Non-Serious Adverse Events | Up to the end of the hospitalisation, until three months corresponding to the end of follow up period |
| Patient discomfort | Up to chest drain removal with an average expected time of 48 hours up to seven days |
| Duration of fever > 38.5°C | Up to fever resolution, with an average expected time of five days to 14 days |
Countries
Belgium
Outcome results
None listed