Health Condition 1: J869- Pyothorax without fistula
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children less than 18 years of age with empyema. There is no lower cut off for age. Empyema will be defined as “presence of pus on a diagnostic pleural tap in children with clinical and/or radiological features consistent with pneumonia and parapneumonic pleural effusion ?.
Exclusion criteria
Exclusion criteria: 1. Prior chest tube drainage with use of intrapleural fibrinolytics or any surgical intervention 2. Contra-indications to fibrinolytic therapy viz 3 Known Coagulopathy or Bleeding disorders 4 Confirmed Pneumothorax or bronchopleural fistula 5 Head trauma during the preceding 2 weeks 6 Children with prior microbiologically confirmed tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The clinical outcome variables will be a.Pleural fluid drainage i.Cumulative amount of intercostal drainage from the insertion of the ICDT to its removal. ii.Total duration of ICDT (in days) b.Time taken for defervescence of fever, resolution of cough, and resolution of respiratory distress (respiratory rate/ chest retractions), improvement in appetite, and improvement in general condition. c.Proportion of children requiring surgical decortication d.Duration of hospitalization e.Proportion of children with treatment failure. Treatment failure will be considered when there is no clinical and/or radiological improvement even after multiple doses of intrapleural intervention decided on case to case basis. 2.Radiological outcome variables will be a.Chest x-ray showing improvement b.USG showing resolution of pleural collection and /or 10mm collection Timepoint: Time point will be different for each participant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.a. Proportion of children developing one or more of the following events: New onset chest pain, Bleeding, Allergic reaction, bronchopleural fistula, pneumothorax, any other event of concern to the child or parent 1.b Mean doses of streptokinase used without any evidence of side effect 2.Marker of Pulmonary function 3 months after discharge viz Spirometry in children = 6 years old, 6-minute walk test in children 3 years old. 3.CXR and USG at 3 months after discharge to document resolution of radiological features of empyema and/or residual pleural thickening. Timepoint: Time point will at the time of discharge of each patient and at 3 months | — |
Countries
India
Contacts
Post Graduate Institute of Medical Education and Research, Chandigarh