Pragmatic non-inferiority Randomised trial Investigating Needle aspiration versus ChEst drain for Secondary Spontaneous Pneumothorax

Inclusion Criteria:

• ≥ 18 years old
• The pneumothorax is of sufficient size and symptoms for the treating physician to consider intervention with ICD, AND
• The patient has a spontaneous secondary pneumothorax; i.e.a pneumothorax occurring in a patient with one of:
  1. Known underlying lung disease OR
  2. ≥ 50 years of age with significant smoking history OR
  3. With suspected underlying lung disease with radiology confirming structural lung disease.

Exclusion Criteria:

• Bilateral pneumothorax
• Traumatic or iatrogenic pneumothorax
• Clinical concerns of tension pneumothorax
• Age < 18 years of age
• Known pregnancy

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 ➡ PRINCE-SSP Tab)

If the patient is eligible:

Step by Step Guide to Recruitment:

In standard working hours; 9-5

• 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:

Consent:

• Obtain a pack from the rack in the ambulance bay:
  • Patients with capacity - use Participant Information Sheet and Consent Form
  • Patients without capacity - use either Personal or Professional Consultee – Use Nominated Consultee Information Sheet and sign Nominated Consultee Consent Form
  

Randomisation:

• Go to this site: PRINCE-SSP Randomisation site
• Login details can be obtained from our sharepoint doc here: Login details
• Follow randomisation choice – i.e. aspiration or ICD using SOC equipment as per CUH policy
• Use EPIC smartphrase .PRINCE for entry in patient records
• EPIC message ED Research Team with patient details
• ED Research Team will complete data collection
• Clinician discretion re discharge or admission
• Place all paperwork in the research letterbox in reception: