Comparing aspiration to chest tube drainage for treating infected fluid around the lung

Not Applicable

Completed

• Conditions: Pleural infection; Respiratory

• Registration Number: ISRCTN84674413
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

2022 Preprint results in https://doi.org/10.21203/rs.3.rs-1552240/v1 (added 10/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36042460/ (added 31/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-05
• Study Completion: 2022-04-30
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patient meeting criteria for pleural infection or complex parapneumonic effusion requiring drainage using international definition (see below):
1. Purulent pleural fluid
2. Pleural fluid pH = 7.2
3. Pleural fluid glucose = 3.4 mmol/L
4. Pleural fluid gram stain and/or culture positive for bacteria
5. Large effusion occupying >50% of hemithorax

Exclusion Criteria

1. RAPID score 5 to 7 (higher risk of mortality)
2. Severe septations/locations on ultrasound (assessed using a validated scoring system)
3. Ongoing sepsis requiring support beyond basic fluid resuscitation
4. Uncorrectable coagulopathy
5. Unable to consent for study
6. Previous pneumonectomy, recent thoracic surgery or indwelling pleural catheter on side of pleural infection
7. Age < 18 years
8. Lives alone with no access to a telephone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility of a randomised trial of chest tube versus thoracentesis in pleural infection, assessed by the proportion of the total number of patients who are eligible for trial entry that accept randomisation. The primary outcome will be defined as successful if =50% of eligible patients are willing to be randomised. Measured at randomisation.