Conservative Management in Traumatic Pneumothoraces in the Emergency Department (CoMiTED) a Randomised Controlled Trial
Background and study aims
In brief, CoMiTED is an NIHR-HTA funded randomised controlled trial to find out whether a collapsed lung (pneumothorax) due to injury (trauma) can be safely and effectively treated without immediately inserting a tube into the chest (chest drain). 750 adult patients with a collapsed lung after trauma will be recruited from (at least) 25 hospital Emergency Departments in the UK.
A collapsed lung (also known as a ‘pneumothorax’) can occur following trauma such as falls, road traffic accidents or knife injuries. We are doing a study to compare different treatment options for a collapsed lung. Currently, doctors treat this condition by inserting a tube (chest drain) through the chest wall, to help the lung re-inflate. Every year, around 25,000 patients in England and Wales have a chest drain inserted. We think that more patients with a collapsed lung could be safely treated without a chest drain, but there is currently no good research evidence one way or the other. The National Institute for Health and Care Research (NIHR) identified this as an area of need and funded our research study to answer the question.
Both treatments for a collapsed lung (treatment with or without a chest drain) have advantages and disadvantages, but we do not know if one is better than the other. This study will help us find out which treatment is better and whether doctors should change their practice and potentially treat fewer patients with a chest drain.
Who can take part (Participate)?
You may be able to take part in this study if you are aged 16 years or older and have been admitted to an Accident and Emergency Department (A&E) with a collapsed lung due to injury. We are hoping that 750 patients in total will take part in this study.
What does the study involve?
The study will consist of two groups of A&E patients, Group 1 and Group 2; participants will be randomly selected to their group. Group 1 will be treated in the usual manner, with a chest drain and hospital admission; Group 2 will be treated without an initial chest drain, using careful monitoring and hospital admission in its place. Once allocated to a group and whilst in A&E, a Researcher will collect general health data from the participant or from their representative (relative/friend). At further fixed time points (30 days, 3 months and 6 months) participants will be asked to complete questionnaires about their health. Some participants may also be asked if they would like to take part in an interview to talk about their experience of taking part in the study.
When did the study start and how long is it expected to run for?
We are currently recruiting to this study (having begun recruitment in August 2022), and will continue to recruit patients until the end of September 2023 (subject to change).
Who is the main contact?
Contact information for the Central Study Office (Team) can be found ‘here’.