Conservative Management of Spontaneous Pneumothoraces in the Emergency Department (CONSEPT): A Randomised Controlled Trial

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.

You will not be able to recruit the patient if there is no member of staff on duty who is on the Delegation Log and has access to the RedCap database – this can be found on SharePoint

Go here: Sharepoint ➡ ED Shared Folders ➡ Research ➡ GCP,CV,Delegation Spreadsheet ➡ CONSEPT Tab)

If the patient is eligible:

Step by Step Guide to Recruitment:

9-5 Monday to Friday:

• Please contact the ED Research Team when eligible patients arrive in ED: Send the ED Research Team a message via Epic chat "ED research Team" or phone 217907

Out of hours and weekends:

1. Collect “CONSEPT per patient pack” from the magazine rack in the ambulance bay, and give the patient the patient information leaflet (PIS) contained in the pack

2. Confirm Eligibility (This must be done by a Dr or a Nurse who is on the Delegation Log)
3. Complete the upper section of the SL1 Screening Form then sign – ‘Name of Clinician confirming Eligibility’. (1/3 of the way down the form). Remember to put MRN in top right corner.
4. Consent the patient (Patient Consent only – the patient must have capacity) and complete consent form.
5. Go to the the online randomisation site: Click here
• Use your own username (nhs.net e-mail) and your own password to log in
• Go to ‘CONSEPT Participants – Tap “Menu” box (top right) -- ‘Record Status Dashboard’—‘Add New Record’
• Complete the ‘Screening’ tab:
  Patient ID– this can be found in the top right corner (xxx-xxx) of SL1 Screening Form
• Click on ‘Randomisation’ tab and enter required data to produce the participant’s trial allocation. Complete form R1 (in the per patient pack for our reference)
6. The randomisation should then be recorded on the notes using the Smart phrase .CONSEPT
7. Ask the patient to complete the patient questionnaire.
8. Inform Patient that they will be followed up by the Pleural Nurse Specialist on the next working weekday
9. Place ALL the documentation (including the questionnaire) in research post box – behind our receptionists

We provide a 24-hour phone line for clinicians, dedicated to addressing any enquiries related to eligibility and randomisation. This is to ensure that you can access crucial information at any time. The number is:

01865 282954

Patient management after randomisation and treatment completed:

• Patients allocated to conservative management (intervention group):
• Observe for a period of around four hours from hospital presentation, but the absolute observation period will be at the discretion of the treating clinician
• If during the observation period any of the following occurs: a) Patient wants intervention due to significant symptoms; b) Patient develops physiological instability (SpO2 <92% on air, respiratory rate>25 breaths per minute); c) Repeat chest radiograph demonstrates an enlarging pneumothorax with clinical concern from a senior clinician (e.g. ST4 or above) with the reason recorded; Then they should switch to usual care (i.e. chest drain).
• After the observation period the participant should be discharged if they meet all of the following criteria: a) Symptoms controlled sufficiently to mobilise comfortably; b) Acceptable vital signs to a senior physician; c) No requirement for supplementary oxygen.
• A minimum clinical follow-up (within 7-10 days time) is recommended for patients managed on the ambulatory or conservative pathway to ensure patient safety, discuss referral to Clinic 5
• A research visit will be conducted at day 30 day (+7 days). At this visit, the patients will undergo a chest radiograph and complete questionnaires to record their pain and breathlessness levels.
• Patients with a chest drain are admitted in the usual way.

Link for further information:

CONSEPT – Bristol Trials Centre

Download study information here

Please contact the ED Research Team when eligible patients arrive in ED:
Send the ED Research Team a message via Epic chat "ED research Team" or phone 217907