Randomised trial of the clinical and cost effectiveness of small bore, Seldinger, versus large bore, surgical, chest drains for the treatment of traumatic haemo/pneumothoraces – (CoMiT-ED 2)
Specialty: Trauma and Emergency Care, Primary sub-specialty: Emergency Medicine; Health Category: Injuries and accidents, Respiratory; Disease/Condition: Injuries to the thorax
Trial design and setting This is a pragmatic multicentre, parallel-group, individually randomised, superiority trial with internal pilot, economic evaluation and integrated QRI. The trial will recruit patients from approximately 50 Major Trauma Centres and Trauma Units across the UK (potentially subject to change and dependent on recruitment rates). Internal pilot: We plan to test trial processes and feasibility using staged enrolment of sites over a 12-month feasibility window, from the time the first participant is recruited. Each site will aim to recruit 2 participants per month. Planned recruitment: On progressing to the main trial period, we will immediately extend recruitment to an additional 35 sites (with staggered opening of 3 sites/month) over a further 21 months. Quintet Recruitment Intervention (QRI): We recognise challenges to trial recruitment in emergency settings, such as out-of-hours patient presentation, multiple inpatient specialities involved in decision making and inherently busy and time-pressured environments. We have planned to address these challenges by integrating the QRI during the internal pilot. The QRI is a mixed-methods intervention developed to optimise recruitment and consent. It involves intensive investigation to understand recruitment challenges and provide training and support to recruiters. It has strong evidence of effectiveness in complex RCTs and comprises two iterative and overlapping phases: Phase 1 - Understanding recruitment: We will investigate factors influencing recruitment (e.g. patient recruitment pathways, eligibility criteria, equipoise issues and other barriers to recruitment and retention) and train recruiters during study setup, combining evidence from previous QRIs and training programmes with data collected from professionals involved in the previous CoMiT-ED trial. Once recruitment starts, we will use a multi-faceted and flexible approach, using triangulation of data, to understand recruitment as it hap
Potential participants must satisfy the following criteria to be enrolled in this study: 1. Patients presenting to hospital with a traumatic pneumothorax, haemothorax or haemopneumothorax (unilateral or bilateral) confirmed on computed tomography (CT) up to 24 hours from presentation; 2. aged, or believed to be aged, 16 years and over 3. AND in whom the treating clinician(s) believes a chest drain is required.
Potential participants who meet any of the following criteria will be excluded from participation: 1. Treating clinician(s) believe injuries are immediately incompatible with life, whereby the patients have no ongoing active management of other injuries or palliation is being undertaken. 2. Patient in cardiorespiratory arrest at the point of randomisation. 3. Retrospective paediatric exclusion if patient confirmed to be less than 16 years.