A trial to investigate whether pleuroscopy can be used to treat pleural infectio

Not Applicable

Completed

• Conditions: Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other acute lower respiratory infections; Respiratory; Pleural infection

• Registration Number: ISRCTN98460319
• Lead Sponsor: Southmead Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-03
• Study Completion: 2019-01-31
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).