Eligibility

Trial population

The target population will be adults up to and including 50 years of age with symptomatic PSP of sufficient size and symptoms causing the treating physician to consider intervention.

Local study conflicts

• Co-enrolment with the RASPER study (IRAS 316434) will be permitted for patients enrolled in the usual care arm of the CONSEPT trial who are treated with a chest drain. Co-enrolment with other studies will be considered by members of the CONSEPT TMG on a case-by-case basis.

Trial population

• The target population will be adults up to and including 50 years of age with symptomatic primary spontaneous pneumothorax (PSP) of sufficient size and symptoms causing the treating physician to consider intervention.

Inclusion Criteria:

• Patients will be eligible for the trial if ALL of the following apply:
• Symptomatic Primary spontaneous pneumothorax (PSP)* of sufficient size to allow intervention
• Age between 16 and 50 years old (inclusive)


• * PSP is defined as a pneumothorax occurring in the absence of trauma and underlying lung disease. An upper age cut off of 50 years of age was selected, as patients above this age are more likely to have underlying lung disease as a cause for their pneumothorax (i.e. secondary and not primary pneumothorax).

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:

Step-by-Step Guide to Recruitment:

In the working hours of the research team:

• Monday-Friday 07:30 – 18:30


• Please contact the EMROx Research Team when eligible patients arrive in ED:
• Mobile 0776818242
  Tel 01865 222003
  Bleep 6680
  Or use the WhatsApp Pneumothorax group - the QR code to join the group will be available in the department.


• Send a message to the Pneumothorax Studies WhatsApp Group both In hours and Out of Hours.

Out of hours and weekends:

Estimated time required:

• 20-25 minutes

Gather documentation

• Participant Information Sheet, Informed Consent Form, and patient questionnaire can be accessed via this link: CONSEPT Recruitment docs (Trust login needed)

Eligibility confirmation

• Delegated Doctors & Nurses can confirm eligibility.
• The delegation log can be accessed via CONSEPT Recruitment docs
• You may need to open https://wiired.org on a desktop PC to be able to print the documents

Formal consent process

• Only Delegated doctors can secure consent
• Only patients with capacity and has signed the ICF will be enrolled to the CONSEPT study.

Randomisation procedure

1. Log in to RedCap:
   https://btcsurvey.bristol.ac.uk/redcap/index.php?action=myprojects
   This is an individual access. REDCap will ask for the Study ID.
3. Enter the required data


4. ** note, the patients study ID number r will be assigned by paper, Or it is the next number at the bottom of the recruitment log. This can be accessed via this link: CONSEPT Recruitment docs


5. Once the data required is entered into RedCap, the patient will be randomised. (REDCap (bristol.ac.uk))

Randomisation Outcome:

1. USUAL CARE The initial pleural procedure administered is at the discretion of the treating clinician. This can be needle aspiration, chest drain or pleural vent.
2. CONSERVATIVE CARE Participants randomised to conservative care should be managed without invasive intervention. Patient will observe for a period of around 4 hours from hospital presentation but the absolute observation period will be at the discretion of the treating clinician.

Following randomisation

• If patient was randomised to conservative care and becomes unwell during the observation period, then they will cross over to usual care and treated with one of the pleural procedures at discretion of treating clinical.
• Complete all data required by RedCap and record patient enrolment into the EPR using the pre-made template. Document in the EPR the name of the clinician that confirmed eligibility; the name of the clinician that formally consented the patient, & time of procedure.
• Ask the patient to complete the patient questionnaire.

Carrying out the intervention:

• Any qualified and trained doctor can do the Needle Aspiration, Chest Drain or Pleural Vent procedure. The doctor must write a note documenting the intervention in the EPR

Completed study documents

• Complete ICF and patient questionnaire must be placed in the EMROx research post box

Disposition and follow-up:

If admitted:

• Standard monitoring according to the procedure received
• The patient wil be followed up by the EMROx team at 48 hours

If discharged:
i.e. Patients allocated to conservative management (intervention group) as safe to discharge:

• 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:
  • Patient wants intervention due to significant symptoms;
  • Patient develops physiological instability (SpO2 <92% on air, respiratory rate>25 breaths per minute);
  • 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:
  • Symptoms controlled sufficiently to mobilise comfortably;
  • Acceptable vital signs to a senior physician;
  • No requirement for supplementary oxygen.

• Inform the patient that they will be followed up by the Research Nurses within the next 24-48 hours
• 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, follow local pathways.
• 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.
• Provide standard safety net advice, written and verbally, for patient with a pneumothorax:
  1. Smokers should be advised to quit and seek assistance from their GP to successfully achieve this (Men who smoke more than 20 cigarettes a day have 100 times the risk of developing a pneumothorax compared to men that don’t smoke.)
  2. avoid flying for at least a week after a chest radiograph has confirmed complete resolution of their spontaneous pneumothorax, or until they have recovered from a definitive cardiothoracic surgical procedure aimed to prevent pneumothorax recurrence
  3. underwater diving should be permanently avoided after a pneumothorax, unless the patient has had bilateral open surgical pleurectomy
  4. They should return for re-assessment should they become breathless
  5. From RCEM Learning module spontaneous pneumothorax (opens in new window)
     
  6. Send the research team a message informing them of the patient with their initials and hospital number to the WhatsApp group (QRc code is found on posters in the department)

Links for further information:

Link to trial centre: CONSEPT – Bristol Trials Centre

Link to Patient Information (and QRc below links to the same site)

If you have issue accessing the study documents and delegation log links please message the team via WhatsApp: ED Research. You can join using the QR code available in the department