Eligibility

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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 in childhood or young adulthood, who do not use any medication, or only occasional 'reliever' medication and have never been hospitalised due to asthma are still be eligible
  • 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

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;

• Any patient found to have pneumothorax bleep ED research Nurses on 81971 or call 39455

Out of hours and weekends:

Gather documentation

• The working file for the study can be found in the research cupboard in majors (outside cubicle 10)

Eligibility

• Only nurses and doctors on the delegation log can confirm eligibility
• If the patient meets criteria, complete the eligibility form and screening log (completed by doctor/delegated nurse)

Formal consent process

• Speak to the patient providing a brief explanation of the trial.
  If the patient is interested provide the PIS (patient information sheet)
• Only patients with capacity can consent to enrollment in this trial
• Complete the consent form

Randomisation procedure

1. Only doctors and nurses on the delegation log will have access to be able to do this:
2. Go to the online randomisation site on a desktop computer: (https://btcsurvey.bristol.ac.uk/redcap/)
• 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)

Carrying out the intervention(s):

• Inform the clinical team of the randomisation;
• proceed to insertion of chest drain as per usual medical care if the patient is randomised to the 'usual care' arm

Disposition and follow-up:

If admitted:

• Patients with a chest drain are admitted in the usual way

If discharged:

• 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


• 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)

Follow-up for discharged patients

• 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.

Link for further information:

CONSEPT – Bristol Trials Centre