Eligibility

Local study conflicts

• None

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

If the patient is eligible:

Step by Step Guide to Recruitment:

In the working hours of the research team:

• Monday-Friday 07:30 – 18:30


• Contact the EMROx research team on:
  Mobile 0776818242
  Tel 01865 222003
  Bleep 6680

Out of hours and weekends:

Estimated time required to enroll

• 20-40 minutes

Gather the documentation

1. The patient information sheet and consent forms are accessed online in the PRINCE-SSP recruitment pack (Trust login required)
   
   
2. The documents you need are:
   
   
   • Study Information Sheet:
   • PRINCE-SSP Detailed PIS V 2.0
   • PRINCE-SSP Consultee Information Sheet
   • PRINCE-SSP Summary PIS
   
   
   • Consent Forms
   • PRINCE-SSP Participant Consent For
   • PRINCE-SSP Consultee Declaration
   • PRINCE-SSP Deferred Consent - patient without capacity



3. You may need to open https://wiired.org on a Trust desktop computer to be able to print these documents

Consenting the patient formally

• When the patient has capacity
• discuss the study with patient. Provide patient with PIS and ICF.
• The patient must sign the consent form


• When the patient has NO capacity: Deferred Consent
• Enrol the patient automatically using deferred consent
• The Study Doctor (ie on the delegation log) and an independent Doctor, who is not on the delegation log, must agree on patient’s participation. This agreement must be documented in the EPR.

Randomisation procedure

• Go to this site: REDCAP (PRINCE-SSP Randomisation site)
• Use the individual login details you were given after you signed the delegation log
• The patient will be randomised to either:
  • Comparator Arm: Needle aspiration (NA)
  • Standard care arm: Chest Drain (ICD) insertion

Carrying out the intervention:

• Any appropriately trained clinician can undertake the treatment
• Record the date and time patient had the Needle Aspiration or Intercostal Chest Drain carried out
• Complete the Screening and Enrolment log both in REDCap and the Screening and Enrolment log in O: - EMROx Nurses

Documentation

• Document in the EPR that the patient was confirmed eligible, and by whom
• Whether informed consent or deferred consent was used; note the names of the study delegated doctor and the independent doctor that gave professional consent
• Which treatment the patient was randomised to; and the time it was carried out

Disposition and follow-up:

All patients will be admitted following the procedure

• Overnight monitoring requirements at clinicians discretion
• Send a message to the EMROx nurses via the whatsapp group that the patient was enrolled.

Further information

Trial information