Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders
Conditions
Interventions
Those who agree to enrolled are first asked to answer questions about their background and previous health. Eligible participants are randomised in a 1:1 ratio using an online (computer-based) system.
Sponsors
Southmead Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pleural effusion due primarily to suspected pleural infection requiring chest tube drainage, defined as an effusion, in the appropriate clinical context, with one or more of the following characteristics: 1.1. Fluid pH =7.20 or visually contains pus 1.2. Pleural fluid glucose =3.4 mmol/L 1.3. Positive bacterial or mycobacterial culture 1.4. Positive gram stain or stain for acid-fast bacilli 2. Clinical team are able to perform a medical thoracoscopy, if allocated, on either the same or the next day as the effusion is diagnosed as requiring drainage 3. Clinical team are able to deliver the post-procedure trial schedule as detailed in the protocol 4. Patient is willing to consider trial entry and receive information sheet
Exclusion criteria
Exclusion criteria: 1. Any contraindication, in the opinion of the trial team or lead clinician, to 1.1. Medical thoracoscopy performed under conscious sedation 1.2. Chest drain insertion 1.3. Trial involvement 2. Patient is unable to provide informed consent 3. Thoracic imaging demonstrating septation or loculation to a degree whereby medical management alone would be inappropriate 4. Maximum pleural fluid depth of =2cm on thoracic ultrasound 5. Ongoing sepsis requiring haemodynamic support beyond basic fluid resuscitation 6. Previous thoracic surgery on the side of the effusion 7. Age <18 8. Pregnancy or lactation 9. Expected survival =3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of screening and enrolling patients into the study, and delivering the trial protocol is measured using the proportion of pre-screen failures, screen failures, and allocation failures compared to the total numbers of patients pre-screened, screened, and randomised (respectively). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of stay due to pleural infection is measured by the number of nights in hospital between enrolment and being recorded as medically fit for discharge 2. Total inpatient time is measured by the number of nights in hospital between enrolment and the end of the 90-day post-procedure follow-up period 3. Need for step-up therapy is measured by the difference in proportion of patients requiring intrapleural fibrinolytic therapy or referral for surgical debridement 4. Lung function is measured by the change in spirometry values (FEV1,FVC and FEV1:FVC ratio) at baseline and days 30 and 90 5. All-cause mortality is measured by the number of patients remaining alive at days 30 and 90 post procedure 6. Degree of pleural fluid septation is measured by the change in bedside thoracic ultrasound septation score at baseline and days one, three, seven, 30 and 90 post procedure 7. Pleural effusion size, is measured by the change in radiographic hemithorax opacification from enrolment to discharge, and days one, 30 and 90 post procedure 8. Microbiological yield is measured by the difference in proportion with positive culture or stain between the control and intervention arms at 90 days 9. Total costs of interventions is measured by the difference in total cost of treatment for pleural infection (from enrolment to being medically fit for discharge) between two arms at 90 days post procedure 10. Quality of life is measured by the change in EQ-5D subjective health score at baseline to days 30 and 90 post procedure 11. Patient experiences are assessed by exploring patients’ perceptions and experiences of interventions before and after their procedure through semi-structured interviews at baseline and study end | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactRahul;Emma Bhatnagar;Keenan
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Outcome results
None listed