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First-line medical thoracoscopy for pleural infection: the SPIRIT randomised controlled feasibility trial
Krishan Ragab Bansal1,2, David T Arnold3,4, Emma Tucker3,4
1Respiratory Medicine, University of Bristol Academic Respiratory Unit, Bristol, UK krb48@cantab.ac.uk.
Background:
Pleural infection remains a significant clinical challenge, requiring hospitalisation, intravenous antibiotics and early chest drain insertion. Medical thoracoscopy (MT), a minimally invasive procedure used electively in the UK for malignant effusions, has demonstrated good outcomes when applied to acute pleural infection in retrospective case series. However, it has not been evaluated as a first-line intervention in the UK in a randomised controlled trial (RCT).
Objectives:
The Studying Pleuroscopy in Routine Pleural Infection Treatment (SPIRIT) trial assessed the feasibility of conducting a full-scale RCT comparing MT with chest drain insertion for acute pleural infection within UK National Health Service (NHS) hospitals.
Methods:
SPIRIT was an open-label, randomised feasibility trial conducted across seven NHS centres between 2017 and 2019. Adults with suspected pleural infection were prescreened; eligible patients were randomised to either chest drain insertion (control) or MT (performed the same or following day) with 90-day follow-up. The primary outcome was feasibility, assessed through a composite of prescreen, screen and allocation failure rates. Secondary outcomes included inpatient-stay duration, mortality, radiological and microbiological outcomes, second-line interventions, patient-reported outcomes and adverse events.
Results:
Of 193 patients prescreened, 181 (93.8%) were excluded due to at least one criterion. Key factors included lack of MT deliverability (49.2%), a not truly infected effusion (45.1%) and contraindications to drainage or study involvement (44.0%). Consequently, the primary feasibility endpoint was not met. All 12 eligible patients were randomised with no attrition. MT lasted 15 min longer than drain insertion, but chest drains remained in situ over 3 days longer (p=0.17) with a longer hospital stay (p=0.57). Radiological improvement, microbiological yield and symptom scores were similar. Adverse events occurred in one control and three MT patients.
Conclusion:
A full-scale RCT is not likely to be feasible in an NHS setting on the proposed protocol. Targeted recruitment from centres equipped for emergency MT may enhance feasibility.
Trial Registration Number:
ISRCTN98460319.
Insights
A feasibility trial found that a full-scale randomized controlled trial (RCT) comparing medical thoracoscopy (MT) with chest drain insertion for pleural infection is unlikely to be feasible in the UK National Health Service (NHS) under the current protocol.
Area of Science:
- Pulmonology
- Thoracic Surgery
- Critical Care Medicine
Background:
- Pleural infection presents a significant clinical challenge, often necessitating hospitalization, antibiotics, and chest drain insertion.
- Medical thoracoscopy (MT) shows promise for acute pleural infection based on retrospective data, but lacks prospective randomized controlled trial (RCT) evaluation as a first-line treatment in the UK.
- The SPIRIT trial aimed to assess the feasibility of a full-scale RCT comparing MT with chest drain insertion for acute pleural infection in UK National Health Service (NHS) hospitals.
Purpose of the Study:
- To evaluate the feasibility of conducting a large-scale randomized controlled trial (RCT) comparing medical thoracoscopy (MT) against standard chest drain insertion for acute pleural infection.
- To determine recruitment rates, screen failure reasons, and allocation success for a potential future definitive trial.
Main Methods:
- An open-label, randomized feasibility trial (SPIRIT) conducted in seven NHS centers (2017-2019).
- Adults with suspected pleural infection were prescreened and randomized to either chest drain insertion or MT.
- Feasibility was assessed via prescreen, screen, and allocation failure rates; secondary outcomes included length of stay, mortality, and adverse events.
Main Results:
- The primary feasibility endpoint was not met, with a high exclusion rate (93.8%) primarily due to lack of MT availability or non-infected effusions.
- Twelve eligible patients were randomized; medical thoracoscopy (MT) procedures were slightly longer, but chest drains remained in place longer.
- Radiological improvement, microbiological yield, and symptom scores were comparable between groups, with a low rate of adverse events.
Conclusions:
- A full-scale RCT comparing MT and chest drain insertion for pleural infection is unlikely to be feasible with the current protocol in an NHS setting.
- Targeted recruitment strategies and utilizing centers with established emergency MT capabilities may improve future trial feasibility.
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