Role of thoracic ultrasonography in pleurodesis pathways for malignant pleural effusions (SIMPLE): an open-label, randomised controlled trial.

BACKGROUND: Pleurodesis is done as an in-patient procedure to control symptomatic recurrent malignant pleural effusion (MPE) and has a success rate of 75-80%. Thoracic ultrasonography has been shown in a small study to predict pleurodesis success early by demonstrating cessation of lung sliding (a normal sign seen in healthy patients, lung sliding indicates normal movement of the lung inside the thorax). We aimed to investigate whether the use of thoracic ultrasonography in pleurodesis pathways could shorten hospital stay in patients with MPE undergoing pleurodesis. METHODS: The Efficacy of Sonographic and Biological Pleurodesis Indicators of Malignant Pleural Effusion (SIMPLE) trial was an open-label, randomised controlled trial done in ten respiratory centres in the UK and one respiratory centre in the Netherlands. Adult patients (aged ≥18 years) with confirmed MPE who required talc pleurodesis via either a chest tube or as poudrage during medical thorascopy were eligible. Patients were randomly assigned (1:1) to thoracic ultrasonography-guided care or standard care via an online platform using a minimisation algorithm. In the intervention group, daily thoracic ultrasonography examination for lung sliding in nine regions was done to derive an adherence score: present (1 point), questionable (2 points), or absent (3 points), with a lowest possible score of 9 (preserved sliding) and a highest possible score of 27 (complete absence of sliding); the chest tube was removed if the score was more than 20. In the standard care group, tube removal was based on daily output volume (per British Thoracic Society Guidelines). The primary outcome was length of hospital stay, and secondary outcomes were pleurodesis failure at 3 months, time to tube removal, all-cause mortality, symptoms and quality-of-life scores, and cost-effectiveness of thoracic ultrasonography-guided care. All outcomes were assessed in the modified intention-to-treat population (patients with missing data excluded), and a non-inferiority analysis of pleurodesis failure was done in the per-protocol population. This trial was registered with ISRCTN, ISRCTN16441661. FINDINGS: Between Dec 31, 2015, and Dec 17, 2019, 778 patients were assessed for eligibility and 313 participants (165 [53%] male) were recruited and randomly assigned to thoracic ultrasonography-guided care (n=159) or standard care (n=154). In the modified intention-to-treat population, the median length of hospital stay was significantly shorter in the intervention group (2 days [IQR 2-4]) than in the standard care group (3 days [2-5]; difference 1 day [95% CI 1-1]; p<0·0001). In the per-protocol analysis, thoracic ultrasonography-guided care was non-inferior to standard care in terms of pleurodesis failure at 3 months, which occurred in 27 (29·7%) of 91 patients in the intervention group versus 34 (31·2%) of 109 patients in the standard care group (risk difference -1·5% [95% CI -10·2% to 7·2%]; non-inferiority margin 15%). Mean time to chest tube removal in the intervention group was 2·4 days (SD 2·5) versus 3·1 days (2·0) in the standard care group (mean difference -0·72 days [95% CI -1·22 to -0·21]; p=0·0057). There were no significant between-group differences in all-cause mortality, symptom scores, or quality-of-life scores, except on the EQ-5D visual analogue scale, which was significantly lower in the standard care group at 3 months. Although costs were similar between the groups, thoracic ultrasonography-guided care was cost-effective compared with standard care. INTERPRETATION: Thoracic ultrasonography-guided care for pleurodesis in patients with MPE results in shorter hospital stay (compared with the British Thoracic Society recommendation for pleurodesis) without reducing the success rate of the procedure at 3 months. The data support consideration of standard use of thoracic ultrasonography in patients undergoing MPE-related pleurodesis. FUNDING: Marie Curie Cancer Care Committee.

Pulmonary passport: a service evaluation study of a standardised web-based procedure logbook to aid specialist respiratory training and appraisal.

INTRODUCTION: The pulmonary passport (PP) is a secure web-based procedural logbook for specialist respiratory trainees with enhanced functionality that includes automated analysis to provide key performance metrics and in-platform interactions with supervisors. METHODS: This service evaluation study used preimplementation and postimplementation online surveys in both trainees and supervisors along with analysis of recorded data within the PP to evaluate the impact of this service on data capture, training, appraisal and quality assurance. RESULTS: From August 2017 to August 2019, 69/73 (95%) specialist respiratory trainees eligible to use the PP across two UK health education deaneries registered with the system and logged 7352 procedures. 3105 thoracic ultrasound procedures identified 2145 pleural effusions and resulted in 1253 pleural procedures of which 96% were successful. 4% of ultrasounds required referral to a more expert sonographer. Iatrogenic bleeding and pneumothorax both occurred in ≤1% of all pleural procedures. 1909 basic diagnostic bronchoscopies were recorded including 1236 bronchial washes, 328 brushes and 221 endobronchial biopsies where definite tumour was identified (biopsy sensitivity 74%). Preimplementation and postimplementation survey data confirmed the PP had increased the consistency of logging procedures by trainees, the depth of data captured, the review of procedural performance metrics in appraisal and the frequency of formal supervisor feedback. DISCUSSION: In this regional project, the implementation of a web-based procedural logbook has been feasible with excellent uptake and has enhanced procedural recording, supervision and appraisal. Furthermore, it provides unprecedented quality assurance at an individual trainee, trust and deanery level and has a number of potential wider applications in the future.

Surgical tracheostomies in COVID-19 patients: A multidisciplinary approach and lessons learned.

Surgical tracheostomies have a role in the weaning process of COVID-19 patients treated in intensive care units. A multidisciplinary team approach (MDT) is required for decision making. This process is augmented by specific standard operating practices implemented by senior clinicians. Here, we report on our early experience and outcomes with open tracheostomies in a cohort of COVID-19 patients. We outline the criteria that guide decision making and explore the challenges faced by our intensive care colleagues in the management of these patients. The cohort was 100% male with 90% of them having a raised Body Mass Index (BMI) and other comorbidities (hypertension and diabetes). 60% have been decannulated and have been stepped down the intensive care unit. We recorded no surgical complications or adverse events. The service to date has been shown to be effective, safe, largely reproducible and reflective.

Providing safe and effective pleural medicine services in the UK: an aspirational statement from UK pleural physicians.

Physicians face considerable challenges in ensuring safe and effective care for patients admitted to hospital with pleural disease. While subspecialty development has driven up standards of care, this has been tempered by the resulting loss of procedural experience in general medical teams tasked with managing acute pleural disease. This review aims to define a framework though which a minimum standard of care might be implemented. This review has been written by pleural clinicians from across the UK representing all types of secondary care hospital. Its content has been formed on the basis of literature review, national guidelines, National Health Service England policy and consensus opinion following a round table discussion. Recommendations have been provided in the broad themes of procedural training, out-of-hours management and pleural service specification. Procedural competences have been defined into descriptive categories: emergency, basic, intermediate and advanced. Provision of emergency level operators at all times in all trusts is the cornerstone of out-of-hours recommendations, alongside readily available escalation pathways. A proposal for minimum standards to ensure the safe delivery of pleural medicine have been described with the aim of driving local conversations and providing a framework for service development, review and risk assessment.