CoMiTED: investigating 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)
| ISRCTN | ISRCTN35574247 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35574247 |
| IRAS number | 312833 |
| Secondary identifying numbers | IRAS 312833, CPMS 52683, Grant Codes: NIHR132889 |
- Submission date
- 27/06/2022
- Registration date
- 04/07/2022
- Last edited
- 11/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
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 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 research 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 participate?
Patients aged 16 years or older who have been admitted to the Accident and Emergency department (A&E), with a collapsed lung due to injury.
What does the study involve?
Participants, when they join the study, will be put into one of two groups. One group will have treatment with a chest drain (current usual care) and the other group will be treated without a chest drain to start with. Participants will be allocated randomly (like tossing a coin) and have an equal chance of receiving either treatment. All participants will be assessed and monitored according to the usual care of the hospital.
Participants will complete questionnaires at 30 days, 3, and 6 months and the study team will review their medical notes.
What are the possible benefits and risks of participating?
In general, the trial will not expose participants to risks additional to routine care. The trial will, however, expose trauma victims to the potential downsides of the established pathways used in clinical practice: those allocated to usual care may have a chest drain inserted without the opportunity for conservative management (and potentially unnecessarily), while a proportion of those allocated to conservative management may be perceived as suffering a delay to the insertion of chest drain that becomes necessary at a later stage in their care. This is supported by PPI. Study procedures will include questionnaires at each time point. This will use the participant's time, but no other inconvenience or risk is expected. The questionnaires have been reviewed by our PPI team to ensure they are acceptable to patients.
By taking part in this study, participants will help to demonstrate whether conservative management is effective and cost-effective in the initial management of traumatic pneumothoraces. This may help and influence the treatment of patients in the future.
Where is the study run from?
North Bristol NHS Trust (UK)
When is the study starting and how long is it expected to run for?
From October 2021 to March 2025
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
Miss Nikki Blythe, nikki.blythe@bristol.ac.uk
Contact information
Principal Investigator
Emergency Department
Southmead Hospital
North Bristol NHS Trust
Southmead Road
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0002-2064-4618 |
|---|---|
| Phone | +44 (0)7595 040112 |
| Ed.Carlton@nbt.nhs.uk |
Public
CoMiTED Study Team
Bristol Trials Centre
Population Health Sciences, Bristol Medical School
University of Bristol
1-5 Whiteladies Road
Clifton
Bristol
BS8 1NU
United Kingdom
| Phone | +44 (0)117 394 0250 |
|---|---|
| comited-trial@bristol.ac.uk |
Scientific
Emergency Department
Southmead Hospital
North Bristol NHS Trust
Southmead Road
Bristol
BS10 5NB
United Kingdom
| ORCID ID |
0000-0002-2064-4618 |
|---|---|
| Phone | +44 (0)7595 040112 |
| Ed.Carlton@nbt.nhs.uk |
Study information
| Study design | Multicentre parallel-group individually randomized controlled non-inferiority trial with an internal pilot, an economic evaluation, and an integrated qualitative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Available at https://comited.blogs.bristol.ac.uk/ |
| Scientific title | Conservative Management in Traumatic Pneumothoraces in the Emergency Department (CoMiTED): A Randomised Controlled Trial |
| Study acronym | CoMiTED |
| Study hypothesis | The aim of this study is to establish whether initial conservative management of significant traumatic pneumothoraces is non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness, and quality of life. |
| Ethics approval(s) | Approved 23/05/2022, Wales REC 4 (Health and Care Research Wales Support Centre, Castlebridge 4 , CF11 9AB; +44 (0)7976 982591; Wales.REC4@wales.nhs.uk), ref: 22/WA/0118 |
| Condition | Traumatic pneumothorax |
| Intervention | Participants will be allocated in a 1:1 ratio to either “initial conservative management (intervention group)” or “chest drain insertion in the ED (control group)”. Randomisation will be carried out using an online system and the randomisation sequence will be generated by the company called “Sealed EnvelopeTM”. Appropriate staff at all sites, as delegated by the PI, will be provided with log-in details for the secure online randomisation system, and study database where applicable. In the intervention (initial conservative management) group, the treating clinician will be advised to manage the participant without chest drain insertion and undertake observation and admission to a hospital ward or ICU. In the control group (chest drain insertion in the ED), it is assumed that all patients will have a chest drain inserted. It is standard practice for chest drains to be inserted immediately after an imaging diagnosis in the ED. Internal pilot: Following set-up, we will carry out an internal pilot for up to six months, at approximately five sites. In this pilot, we aim to confirm the feasibility of the trial processes including, recruitment of participants, randomisation, and adherence to the allocated intervention arm. Detailed information will be gathered during the internal pilot from both the qualitative and quantitative elements of the study to inform optimisation and refinement of study processes. Completeness of TARN data and number of randomised trial patients who are eligible for TARN inclusion will be established during the internal pilot to streamline data collection for the main trial. The pilot will be evaluated using quantitative progression criteria and a qualitative exploration of the acceptability of the trial. Participants recruited to the internal pilot will be included in the final analysis. On progressing to the main trial recruitment period, we will immediately extend recruitment to approximately 20 additional sites for a further 12 months recruitment. Baseline questionnaire: ‘’Baseline’’ data collection will take place after initial enrolment (randomisation) in the ED has taken place. Participants will be asked to complete the questionnaire according to how they feel at the time of completion, rather than retrospectively. Follow up: Participants will be contacted at 30 days (+10 days) following randomisation, 3 months, and 6 months (-/+ 10 days) to complete a follow-up study questionnaire, which will include questions about their pain and function, breathlessness, quality of life and wellbeing. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Need for one or more subsequent emergency pleural interventions (excluding chest drain insertion in the ED) measured using patient records/electronic patient tracking systems up to 30 days |
| Secondary outcome measures | The following will be measured at specified timepoints post-randomisation: 1. All pleural interventions (including chest drain insertion in the ED) measured using patient records/electronic patient tracking systems up to 30 days 2. All complications of pleural intervention measured using patient records/electronic patient tracking systems up to 30 days 3. Total days of pleural drainage measured using patient records/electronic patient tracking systems up to 30 days 4. Patient-reported pain, function, and breathlessness measured using validated Brief Pain Inventory and MRC dyspnoea scale (Patient Reported Outcome Measures) at baseline, 30 days, 3 and 6 months 5. Quality of life measured using EQ-5D-5L questionnaire and Impact of Events Scale-Revised at 30 days, 3 and 6 months 6. Total length of stay (hospital and Intensive Care Unit (ICU), including readmission) measured using patient records/electronic patient tracking systems up to 30 days 7. Adjudicated mortality (pneumothorax or chest injury related) measured using patient records/electronic patient tracking systems at 30 days 8. All-cause mortality measured using patient records/electronic patient tracking systems at 6 months 9. Cost per quality-adjusted life year (QALY) measured using the data collected in secondary outcomes "1., 2., 4., 5., 6., 7., and 8." supplemented by a study-specific patient resource use questionnaire at 6 months 10. Patient/consultee views and experiences of conservative management/chest drain measured using qualitative interviews at 30 days and 6 months 11. Clinician views of conservative management/chest drain measured using qualitative interviews throughout the trial |
| Overall study start date | 01/10/2021 |
| Overall study end date | 02/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 400; UK Sample Size: 400 |
| Total final enrolment | 400 |
| Participant inclusion criteria | 1. Presenting to the Emergency Department with traumatic pneumothoraces 2. Aged, or believed to be aged, ≥16 years 3. The treating clinician(s) are uncertain if a chest drain is required |
| Participant exclusion criteria | 1. Treating clinician(s) believe injuries are incompatible with life 2. Respiratory arrest 3. Haemothorax requiring a chest drain in the opinion of the treating clinician(s) 4. Clinical and imaging evidence of tension pneumothorax 5. Prisoners (does not include those in police custody; only those detained in prison establishments) 6. Retrospective paediatric exclusion if patient confirmed to be aged <16 years |
| Recruitment start date | 08/08/2022 |
| Recruitment end date | 31/01/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Newton Road
Torquay
TQ2 7AA
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Taunton
TA1 5DA
United Kingdom
Hull
HU3 2JZ
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
Leeds
LS1 3EX
United Kingdom
London
W2 1NY
United Kingdom
Cwmbran
NP44 8YN
United Kingdom
Bath
BA1 3NG
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Liverpool
L9 7AL
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Poole
BH15 2JB
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Coventry
CV2 2DX
United Kingdom
Cramlington
NE23 6NZ
United Kingdom
Southampton
SO16 6YD
United Kingdom
Tonbridge Road
Pembury
Tunbridge Wells
TN2 4QJ
United Kingdom
Bury St Edmunds
IP33 2QZ
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Bristol
BS2 8HW
United Kingdom
Broomfield
Chelmsford
CM1 7ET
United Kingdom
Watford
WD18 0HB
United Kingdom
Birmingham
B15 2TH
United Kingdom
250 Euston Road
London
NW1 2PG
United Kingdom
Belfast
BT12 6BA
United Kingdom
Harlow
CM20 1QX
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Edinburgh
EH16 4SA
United Kingdom
Merthyr Tydfil
CF47 9DT
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation
North Bristol NHS Trust Floor 3
Learning & Research Building
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)1174149330 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The aim will be to publish our primary manuscript in a high impact medical journal, and present our findings at multiple conferences. We will communicate our findings to the British Thoracic Society, NICE, and NHS England to incorporate our work into relevant national guidelines and develop a film about the project with the help of involved patients and our patient advisors to ensure our findings reach diverse audiences. We will also complete a full report for the NIHR. |
| IPD sharing plan | The dataset will be published in the publicly available University of Bristol Research Data repository (https://www.bristol.ac.uk/staff/researchers/data/accessing-research-data/). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.0 | 07/07/2022 | 19/07/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 6.0 | 23/02/2024 | 29/04/2024 | No | No |
| Protocol article | 17/06/2024 | 19/06/2024 | Yes | No | |
| Protocol file | version 7.0 | 23/07/2024 | 08/10/2024 | No | No |
Additional files
Editorial Notes
11/03/2025: Total final enrolment added.
22/01/2025: The following changes were made to the trial record:
1. The overall end date was changed from 31/07/2025 to 02/03/2025.
2. The intention to publish date was changed from 31/07/2026 to 31/12/2025.
3. The plain English summary was updated to reflect these changes.
4. The participant level data sharing statement was added.
08/10/2024: The following changes were made:
1. Uploaded protocol V7.0 (not peer reviewed).
2. The target number of participants was changed from Planned Sample Size: 750; UK Sample Size: 750 to Planned Sample Size: 400; UK Sample Size: 400.
15/08/2024: The following changes were made:
1. The overall study end date was changed from 31/03/2026 to 31/07/2025.
2. The recruitment end date was changed from 30/09/2025 to 31/01/2025.
3. The Royal Liverpool Hospital was added as a study participating centre.
4. The intention to publish date was changed from 31/03/2027 to 31/07/2026.
19/06/2024: Publication reference added.
29/04/2024: Uploaded protocol V6.0 (not peer reviewed).
08/04/2024: The following changes were made:
1. The study participating centres University College London, Royal Victoria Hospital, Princess Alexandra Hospital, Victoria Hospital, Royal Infirmary of Edinburgh, Prince Charles Hospital and Northern General Hospital were added.
2. The study participating centre Walsgrave General Hospital was removed.
3. The recruitment end date was changed from 31/05/2024 to 30/09/2025.
4. The overall study end date was changed from 08/06/2024 to 31/03/2026.
5. The intention to publish date was changed from 30/09/2025 to 31/03/2027.
18/12/2023: The recruitment end date was changed from 08/12/2023 to 31/05/2024.
11/12/2023: The following changes were made:
1. Salford Royal NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Kettering General Hospital NHS Foundation Trust, Surrey and Sussex Healthcare NHS Trust, Southport And Ormskirk Hospital NHS Trust, Frimley Health NHS Foundation Trust, University Hospitals Of North Midlands NHS Trust, and King's College Hospital NHS Foundation Trust study participating centres were removed.
2. University Hospital (Coventry), Northumbria Specialist Emergency Care Hospital, Southampton General Hospital, Tunbridge Wells Hospital, West Suffolk Hospital, University Hospital of Wales, Gloucestershire Royal Hospital, Bristol Royal Infirmary, Broomfield Hospital, Watford General Hospital, and Queen Elizabeth Hospital study participating centres were added.
12/09/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 30/09/2023 to 08/12/2023.
2. The overall study end date was changed from 30/09/2024 to 08/06/2024.
3. Addenbrooke’s Hospital, Musgrove Park Hospital, Hull Royal Infirmary, James Cook University Hospital, Macclesfield District General Hospital, Royal Victoria Infirmary, Leeds General Infirmary, St Mary’s Hospital, Grange University Hospital, Royal United Hospital, Milton Keynes University Hospital, Aintree University Hospital, John Radcliffe Hospital, Poole Hospital, and Northwick Park Hospital were added as study participating centres.
08/08/2022: The recruitment start date was changed from 30/07/2022 to 08/08/2022.
19/07/2022: Uploaded protocol (not peer reviewed).
27/06/2022: Trial’s existence confirmed by the National Institute for Health and Care Research.
