Early Video-assisted Thoracoscopic Surgery or Intrapleural Enzyme Therapy in Pleural Infection: A Feasibility Randomized Controlled Trial. The Third Multicenter Intrapleural Sepsis Trial—MIST-3Eihab O. Bedawi, Dionisios Stavroulias, Emma Hedley et al.|American Journal of Respiratory and Critical Care Medicine|2023 Abstract Rationale Assessing the early use of video-assisted thoracoscopic surgery (VATS) or intrapleural enzyme therapy (IET) in pleural infection requires a phase III randomized controlled trial (RCT). Objectives To establish the feasibility of randomization in a surgery-versus-nonsurgery trial as well as the key outcome measures that are important to identify relevant patient-centered outcomes in a subsequent RCT. Methods The MIST-3 (third Multicenter Intrapleural Sepsis Trial) was a prospective multicenter RCT involving eight U.K. centers combining on-site and off-site surgical services. The study enrolled all patients with a confirmed diagnosis of pleural infection and randomized those with ongoing pleural sepsis after an initial period (as long as 24 h) of standard care to one of three treatment arms: continued standard care, early IET, or a surgical opinion with regard to early VATS. The primary outcome was feasibility based on >50% of eligible patients being successfully randomized, >95% of randomized participants retained to discharge, and >80% of randomized participants retained to 2 weeks of follow-up. The analysis was performed per intention to treat. Measurements and Main Results Of 97 eligible patients, 60 (62%) were randomized, with 100% retained to discharge and 84% retained to 2 weeks. Baseline demographic, clinical, and microbiological characteristics of the patients were similar across groups. Median times to intervention were 1.0 and 3.5 days in the IET and surgery groups, respectively (P = 0.02). Despite the difference in time to intervention, length of stay (from randomization to discharge) was similar in both intervention arms (7 d) compared with standard care (10 d) (P = 0.70). There were no significant intergroup differences in 2-month readmission and further intervention, although the study was not adequately powered for this outcome. Compared with VATS, IET demonstrated a larger improvement in mean EuroQol five-dimension health utility index (five-level edition) from baseline (0.35) to 2 months (0.83) (P = 0.023). One serious adverse event was reported in the VATS arm. Conclusions This is the first multicenter RCT of early IET versus early surgery in pleural infection. Despite the logistical challenges posed by the coronavirus disease (COVID-19) pandemic, the study met its predefined feasibility criteria, demonstrated potential shortening of length of stay with early surgery, and signals toward earlier resolution of pain and a shortened recovery with IET. The study findings suggest that a definitive phase III study is feasible but highlights important considerations and significant modifications to the design that would be required to adequately assess optimal initial management in pleural infection.The trial was registered on ISRCTN (number 18,192,121).
The impact of outpatient<i>versus</i>inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised clinical trialParthipan Sivakumar, Deirdre Fitzgerald, Hugh Ip et al.|European Respiratory Journal|2023 BACKGROUND: The principal aim of malignant pleural effusion (MPE) management is to improve health-related quality of life (HRQoL) and symptoms. METHODS: In this open-label randomised controlled trial, patients with symptomatic MPE were randomly assigned to either indwelling pleural catheter (IPC) insertion with the option of talc pleurodesis or chest drain and talc pleurodesis. The primary end-point was global health status, measured with the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) at 30 days post-intervention. 142 participants were enrolled from July 2015 to December 2019. RESULTS: Of participants randomly assigned to the IPC (n=70) and chest drain (n=72) groups, primary outcome data were available in 58 and 56 patients, respectively. Global health status improved in both groups at day 30 compared with baseline: IPC (mean difference 13.11; p=0.001) and chest drain (mean difference 10.11; p=0.001). However, there was no significant between-group difference at day 30 (mean intergroup difference in baseline-adjusted global health status 2.06, 95% CI -5.86-9.99; p=0.61), day 60 or day 90. No significant differences were identified between groups in breathlessness and chest pain scores. All chest drain arm patients were admitted (median length of stay 4 days); seven patients in the IPC arm required intervention-related hospitalisation. CONCLUSIONS: While HRQoL significantly improved in both groups, there were no differences in patient-reported global health status at 30 days. The outpatient pathway using an IPC was not superior to inpatient treatment with a chest drain.
Clinical and survival differences during separate COVID-19 surges: Investigating the impact of the Sars-CoV-2 alpha variant in critical care patientsA number of studies have highlighted physiological data from the first surge in critically unwell Covid-19 patients but there is a paucity of data describing emerging variants of SARS-CoV-2, such as B.1.1.7. We compared ventilatory parameters, biochemical and physiological data and mortality between the first and second COVID-19 surges in the United Kingdom, where distinct variants of SARS-CoV-2 were the dominant stain. We performed a retrospective cohort study investigating critically unwell patients admitted with COVID-19 across three tertiary regional ICUs in London, UK. Of 1782 adult ICU patients screened, 330 intubated and ventilated patients diagnosed with COVID-19 were included. In the second wave where B.1.1.7 variant was the dominant strain, patients were had increased severity of ARDS whilst compliance was greater (p<0.05) and d-dimer lower. The 28-day mortality was not statistically significant (1st wave: 42.2% vs 2nd wave: 39.8%). However, when adjusted for key covariates, the hazard ratio for 28-day mortality in those patients with B.1.1.7 was 3.79 (CI 1.04-13.8; p = 0.043) compared to the original strain. During the second surge in the UK, where the COVID-19 variant B.1.1.7 was most prevalent, significantly more patients presented to critical care with severe ARDS. Furthermore, mortality risk was significantly greater in our ICU population during the second wave of the pandemic in those patients with B.1.1.7. As ICUs are experiencing further waves (particularly by the delta (B.1.617.2) variant), we highlight the urgent need for prospective studies describing immunological and pathophysiological differences across novel emerging variants.
P201 Evaluating and supporting community care of patients with indwelling pleural catheters in inner London<h3>Background</h3> Indwelling pleural catheters (IPCs) are a recommended first line treatment option in the management of malignant pleural effusions. The MY-IPC study highlighted the variability of psychosocial impacts experienced by patients with IPCs, with quality of community care being a key modulatory factor. <h3>Aims</h3> 1. Investigate the training, confidence, and experience of district nurses (DNs) in managing IPCs and identify commonly encountered issues <b>2.</b> Develop and implement strategies to support DNs based on the above <h3>Methods</h3> A questionnaire evaluating aim 1 was designed and distributed to DNs working in two central London boroughs between January and February 2024 (figure 1). <h3>Results</h3> 19 responses were received. 16/19 (84%) respondents felt fairly or very confident looking after IPC patients, with 8/19(42%) having looked after an IPC within the last 3 months.17/19 (89%) respondents had received some form of training on IPC management, ranging from formal training to informal ‘on the job’ training. Of those trained, 5/17 (29%) were not satisfied with the training received. Key issues reported by DNs when looking after IPC patients included medical problems (drainage haemodynamic parameters, blockages, infection, pain), managing patient expectations and absence of patient care plans. 4/17 (24%) did not know how to order more bottles. 10/17 (59%) did not have contact details for the secondary care teams to contact with queries. DN perceived challenges that patients faced with community IPC care included medical and practical drainage issues; none recognised wait time for community drainage as a challenge. When asked how they could be better supported in looking after IPC patients, 16/19 (84%) felt more frequent training on IPC management would be helpful. <h3>Outcome</h3> Given the heterogenous training, confidence, and experience of IPC management amongst DNs, the following strategies were instigated to support them. 1) Biannual secondary care led training sessions on IPC management and troubleshooting focusing on DN highlighted issues. The first session received highly positive feedback with 8/9 (89%) of post-attendance respondents reporting an increase in their confidence managing IPCs. 2) Crib sheet on troubleshooting IPC related issues with consolidated contact information for local secondary care teams and industry liaisons to facilitate communication
P78 The role of the general medical registrar in performing out-of-hours pleural procedures: a UK national survey of trainee and trainer perspectives<h3>Introduction</h3> Pleural procedural competencies are part of the UK general internal medicine (GIM) curriculum, with a widespread expectation that GIM registrars should be able to perform these procedures out-of-hours (OOH) if required. GIM registrar exposure to pleural procedures has declined, with procedures increasingly done by specialists in-hours. Pleural interventions risk significant harm. We explored GIM registrars’ perceived competence and confidence in performing OOH pleural procedures, from the perspective of both GIM registrars and respiratory consultants. <h3>Methods</h3> An anonymised survey was distributed to non-respiratory GIM registrars and respiratory consultants across the UK. <h3>Results</h3> We received responses from 389 registrars (representing all training grades and 14 specialties) and 93 consultants (including 12 with training programme director experience). Only 37% of registrars reported being ‘signed-off’ as independent in inserting a chest drain for pneumothorax. 69% had not done a pleural procedure for at least a year. Regarding perceived confidence for OOH chest drain insertion for pneumothorax, 42% of registrars reported no confidence to perform the procedure even if directly supervised, with only 11% feeling confident to do it unsupervised. Respiratory consultants were asked to rate the pleural procedural competence of an average non-respiratory GIM registrar, 88% felt they would require supervision and only 4% felt they could perform the procedure unsupervised. 56% of respiratory consultants felt that pleural competencies in the internal medicine curriculum should be changed or removed. Common themes in the free text included anxiety surrounding pleural procedures, patient safety concerns, insufficient available training opportunities to maintain competency and differing opinions on the changing role of the medical registrar and who should be expected to perform OOH pleural procedures. <h3>Conclusions</h3> Our findings suggest that the majority of UK non-respiratory GIM registrars lack both competence and confidence to independently perform OOH pleural procedures, according to both trainees and trainers. This raises concerns for patient safety and service delivery, highlighting the urgent need to review GIM training, curriculum, and OOH pleural procedural provisions.