Traumatic pneumothorax Injury, Occupational Diseases, Poisoning
Conditions
Interventions
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
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactNikki Blythe
Outcome results
None listed