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)

Research Question: In the management of patients with traumatic haemopneumothoraces that require a chest drain, is a small bore chest drain (=14Fr), inserted using a Seldinger technique, superior to a large bore chest drain (>24Fr), inserted using a surgical technique, in terms of major complication rates at 30 days? Background: Traumatic haemopneumothoraces occur in 1 in 5 victims of trauma. [6] Current standard of care is the insertion of large bore, surgical, chest drain with the aim of removing blood and air from the pleural space. [7] However, our patients describe the insertion as traumatising (“it’s brutal”) and large drains have a complication rate of up to 20%. [8, 9] Two small Randomised Controlled Trials (RCTs) in the United States (US) have demonstrated that smaller bore (=14Fr) chest drains inserted via a Seldinger technique may be more effective and have fewer complications when compared to larger drains. Aims: To establish if small bore (=14Fr) Seldinger chest drains are superior to large bore (=24 Fr) surgical chest drains in terms of major complication rates at 30 days, in adult patients presenting to hospital with traumatic chest injury requiring a chest drain up to 24 hours from presentation. Objectives: a) To establish if small bore drains are superior to a large bore drains in terms of major complications at 30 days in traumatic haemo/pneumothorax. b) To determine the difference between small bore drains and large bore drains in terms of health-related quality of life and patient reported outcomes. c) To determine the clinical and cost effectiveness of small bore drains. d) To understand and mitigate barriers to recruitment in the acute trauma setting. Methods: A pragmatic multicentre, parallel group, individually randomised, superiority trial with internal pilot, economic evaluation and integrated Qualitative research integrated in Trials Recruitment Intervention. Participants will be recruited from 50 Major Trauma Centres and Trauma Units in the UK. 1678 adult patients with traumatic haemopneumothorax in whom the treating clinician is certain a chest drain is required will be randomised 1:1 to either small bore (intervention) or large bore (control) chest drain. The primary outcome is major complications at 30 days. Secondary outcomes aim to capture clinical effectiveness of small bore drains and key patient reported outcomes. Timelines for Delivery (months): 50 months. Approvals - months 0-3; pilot set-up - months 3-8; pilot recruitment - months 8-20; all site recruitment - months 20-41; follow-up - months 41-47; analysis and dissemination - months 47-50. Anticipated impact and Dissemination: To support the rapid translation of results into practice, an Impact Plan will be designed. Membership will ensure representation across micro through to macro levels of adopters. It will have Patient Advisory Group representation and meet to coincide with trial progression milestones. We will use power of patient stories to capture lived experience of different types of chest drain. Dissemination methods will be diverse and selected to reflect target audiences, their preferences and the message being communicated. Results will be shared in traditional communication channels (high-impact journals and specialty conferences) along with digital fora such as websites, social media, short films and, where appropriate, mass media.