Empyema of Lung treatment.

Phase 2

• Conditions: Health Condition 1: null- Diagnosed and confirmed as Empyema thoracis stage-II

• Registration Number: CTRI/2018/08/015361
• Lead Sponsor: AIIMS Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients adults (more than 18 years) diagnosed as Empyema thoracic in fibrinopurulent stage-II.

2. Thoracic empyema will be defined as pleural effusion that fulfilled at least one of following criteria:

(a) Presence of frank pus on pleural aspiration.

(b) Presence of organism on pleural fluid culture.

(c) Positive pleural fluid Gram stain.

3. Tuberculous empyema will be defined as empyema with one of following:

(a) Pleural fluid smear positive for acid fast bacilli (AFB).

(b) Sputum positive for AFB and radiological lesions consistent with active parenchymal tuberculosis on chest x-ray/CT scan of thorax .

(c) CBNAT Study

4. Probable tuberculous empyema will be defined as empyema with radiological evidence of active pulmonary tuberculosis on chest x-ray/CT scan of thorax with sputum negative for AFB.

Exclusion Criteria

1. Age less than 18 years.

2. Empyema secondary to penetrating chest trauma.

3. Empyema secondary to or following any thoracic surgical procedure.

4. Empyema due to carcinoma or terminally ill patients.

5. Patients not fit for surgery/intervention.

6. Patients with co morbid diseases like cardiac disorders and immunosuppression.

7. Unwilling/No consent for participation in study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To cure from Empyema <br/ ><br>1. expansion of Lung <br/ ><br>2. No residual Infection in Pleural cavityTimepoint: To cure from Empyema - AFTER 1 Month of starting treatment <br/ ><br>1. expansion of Lung <br/ ><br>2. No residual Infection in Pleural cavity

Secondary Outcome Measures

Name	Time	Method
1. Post procedural air-leak duration <br/ ><br>2. Duration of chest tube in situ <br/ ><br>3. Hospital stay duration <br/ ><br>4. Time to return to work <br/ ><br>5. Treatment failure / re-operation <br/ ><br>6. Mortality <br/ ><br>7. Other complications <br/ ><br>Timepoint: At the End of Trial. Each patient data will be analyzed.