{
  "abstract": "Introduction Secondary spontaneous pneumothorax (SSP) is a medical emergency where the lung collapses in the presence of underlying chronic lung disease. Current international clinical guidelines recommend the insertion of an intercostal chest drain (ICD) for SSP. However, needle aspiration (NA) is a simpler and quicker procedure, is less painful and associated with fewer complications than ICD. The primary objective of PRINCE-SSP was to test whether NA is non-inferior to ICD for the initial length of hospital stay (LOHS) during 30 days from randomisation.Methods PRINCE-SSP was an efficient, pragmatic, multi-centre, open-label, parallel, two-group, randomised, non-inferiority trial conducted in 20 UK hospitals over a 2-year period. Eligible patients had to have an SSP. Patients could be enrolled either by giving informed consent if they had capacity or via a deferred consent pathway, whereby consent was sought if the patient regained capacity within 72 hours of randomisation or else from a personal or nominated consultee. Participants were randomly allocated to the intervention (NA) or usual care (ICD) and followed up for at least 30 days. The primary outcome is initial LOHS up to day 30 post-randomisation, with pre-specified non-inferiority margin of +1 day.Results Between August 18, 2023 and April 30, 2025, 303 patients were screened. 72 eligible patients were enrolled and randomised: 37 to NA and 35 to ICD. One patient (randomised to ICD) was subsequently found not to have a pneumothorax, prior to receiving any trial treatment, and was excluded from any further trial activities.The mean (SD) age of the remaining 71 participants was 65.6 (13.5) years, with range 37 to 91; 55 (77.5%) were men; 88.7% were white; 64.8% had COPD and 54.9% had recurrent pneumothorax. The median pneumothorax size at the hilum was 3.55 cm (range 0 to 13.1). Baseline characteristics were generally well-balanced between allocated groups. Three deaths were reported: two during the initial hospital stay (one in each allocated group) and one death (ICD) reported after the initial hospital stay.Conclusion Final follow-ups were in June 2025 and analyses are now underway. Results on clinical effectiveness and implications for practice will be presented and discussed.",
  "authors": [
    {
      "affiliations": [
        "Academic Respiratory Unit, University of Bristol, Bristol, UK",
        "North Bristol NHS Trust, Westbury on Trym, Bristol, UK"
      ],
      "name": "S Walker"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "E Taylor"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "A McAndrew"
    },
    {
      "affiliations": [
        "North Bristol NHS Trust, Westbury on Trym, Bristol, UK",
        "University of Bristol, Bristol, UK"
      ],
      "name": "E Carlton"
    },
    {
      "affiliations": [
        "North Bristol NHS Trust, Westbury on Trym, Bristol, UK"
      ],
      "name": "E Chaudhuri"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "P Ghorpade"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "C Goodwin"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "J Connors"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "A Palmer-Walsh"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "H Cook"
    },
    {
      "affiliations": [
        "Health Economics Research Centre, University of Oxford, Oxford, UK"
      ],
      "name": "R Luengo-Fernandez"
    },
    {
      "affiliations": [
        "Exeter Clinical Trials Unit, University of Exeter, Exeter, UK"
      ],
      "name": "S Creanor"
    },
    {
      "affiliations": [
        "Academic Respiratory Unit, University of Bristol, Bristol, UK"
      ],
      "name": "NA Maskell"
    }
  ],
  "title": "S152 Pragmatic non-inferiority randomised trial investigating needle aspiration versus chest drain for secondary spontaneous pneumothorax. The PRINCE-SSP study",
  "uid": "95d958bd-9bd3-58cf-8248-38fcf3774798"
}