Eligibility
Local study conflicts
- None
Inclusion Criteria:
- Spontaneous Pneumothorax
- Age between 16 and 50 years old (inclusive)
Exclusion Criteria:
- Evidence of clinical tension pneumothorax
- SpO2 <92% on air
- Bilateral pneumothorax
- Pregnancy
- Inability to consent or comply with trial requirements.
- Known or suspected underlying lung disease:
- Patients with a diagnosis of asthma who are on regular preventer medication or a history of ever having been admitted to hospital for asthma are excluded. Patients who do not use any medication, or only occasional 'reliever' medication would still be eligible.
If the patient is eligible:
- Gain verbal agreement in principle before proceeding. Explain:
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition
- If they change their mind they can withdraw their participation at any point
Step-by-Step Guide to Recruitment:
In standard working hours; Monday to Friday 0730-1630
- Please contact the Trauma Hub on 07889 476009
Out of hours and weekends:
- Eligibility can only be confirmed by doctor or nurse who is on the delegation log
- Collect pack from the concept box behind the workstation in resus
- Patient must have capacity to consent
- Complete SL1 screening form and sign to confirm eligibility.
- Generic log in details are on top of the consept box to log onto database and randomise
- Screening ID is the number in the top right hand corner of the SL1 form.
- On the database go to concept participants, tap record status, add record, complete screening tab.
- Click on randomisation tab entering data to proceed to trial allocation.
- Follow randomisation allocation.
- Put completed paperwork in the brown envelope in the concept box.
- Document in notes
Patient management following randomisation
Patients allocated to conservative management will need a period of observation >4hrs, if during this time patient remains stable they may be discharged home at the treating clinicians discretion. Follow up will be arranged by research nurse. If the patient condition deteriorates significantly to cause concern, then the treating clinician should switch to the usual care (chest drain) if necessary.