Pleural infection Respiratory
Conditions
Interventions
At the time of diagnosis of pleural infection, potential patients are approached to be invited to participate. Patients will be randomized 1:1 using the REDCap randomisation module (stratified by size
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of pleural procedures required before resolution of infection, measured using cumulative totals at 90 days 2. Requirement for intrapleural fibrinolytics, measured using cumulative totals at 90 days 3. Hospital Length of Stay (days) and readmission rates measured using cumulative totals within 30 days 4. Number of patients requiring surgical intervention measured as a proportion of the total number randomised at 30 and 90 days 5. All-cause mortality measured by the number of patients alive at days 30 and 90 6. Validity of lung function testing (measured as % predicted of forced volume vital capacity) at 90 days 7. Patient-reported outcomes measures (PROMS), including health-related quality of life (HRQoL)-using the EQ-5D-5L questionnaire and Visual Analog Score (VAS) for chest pain and shortness of breath at baseline, day 3, day 7, day 30 and day 90 8. Total costs of interventions, measured by the difference in costs between the treatment arms at 90 days. In order to complete a health economic analysis, information on additional visits to primary or secondary care, social care and informal carer costs will be collected 9. Pleural thickening measured using chest radiograph at baseline and 90 days | — |
Countries
England, United Kingdom
Contacts
Public ContactDavid Arnold
Outcome results
None listed