{
  "abstract": "Introduction For large primary spontaneous pneumothorax (PSP), drainage or simple aspiration are the two first-line treatment options. Outpatient ambulatory strategies have a success rate of almost 80% with few complications. New French recommendations suggest that an outpatient strategy should be preferred if an appropriate care network is in place. However, establishing this care network remains the main obstacle to the use of this strategy. Thus, outpatient management of PSP remains rare, which is neither optimal for the patient, with a likely impact on quality of life (QOL) and satisfaction with care, nor for the healthcare system, with increased costs. We hypothesise that outpatient treatment of PSP compared with usual inpatient management could improve quality of care and represent a more efficient, generalisable and sustainable strategy.Methods and analysis In this multicentre, cluster-controlled, randomised interventional study with stepped wedge implementation, patients aged 18–50 presenting to the emergency department (ED) with a first episode of large PSP will be enrolled in seven university hospitals in France. The main objective of this study is to evaluate the impact on changes in QOL of an ambulatory strategy for the management of large PSP in the ED compared with usual inpatient management. The primary outcome is the difference in QOL as measured by SF-36 score, between drain placement and 6 months. Clinical criteria (pulmonary expansion at 6 days, pain, dyspnoea, complications, recurrence), perceived quality of care (satisfaction, patient preference, anxiety) and ease of implementation of the care pathway will also be assessed. A cost-utility analysis will be carried out to evaluate the incremental cost-utility ratio at 1 year, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores.Ethics and dissemination Ethics approval has been obtained by the Comité de Protection des Personnes Nord Ouest III N° 2024-36. Study findings will be disseminated by publication in a high-impact international journal. Results will be presented at national and international emergency healthcare meetings, and participating patients notified of the main conclusions.Trial registration number This trial is registered with Clinical Trials Registry NCT06471608. The trial protocol and statistical design are fully described in this study protocol. Additional data can be provided on reasonable request to the sponsor. Protocol version: V2.1 - 21/11/2024.",
  "authors": [
    {
      "affiliations": [
        "Emergency department, University Hospital Centre Strasbourg, Strasbourg, France",
        "ICube, Illkirch, Grand Est, France"
      ],
      "name": "Sabrina Kepka"
    },
    {
      "affiliations": [
        "Emergency department, University Hospital Centre Strasbourg, Strasbourg, France",
        "ICube, Illkirch, Grand Est, France"
      ],
      "name": "Valérie Wilmé"
    },
    {
      "affiliations": [
        "URCEco, AP-HP, Paris, France"
      ],
      "name": "Martin Duracinsky"
    },
    {
      "affiliations": [
        "Pneumologie Unit, University Hospital Centre Strasbourg, Strasbourg, France"
      ],
      "name": "Cezar Matau"
    },
    {
      "affiliations": [
        "URCEco, AP-HP, Paris, France"
      ],
      "name": "Arnaud Nze Ossima"
    },
    {
      "affiliations": [
        "Department of Emergency, University Hospital Centre Bordeaux, Bordeaux, France",
        "Injury Epidemiology Trauma and Occupation Team, ISPED, Bordeaux, France"
      ],
      "name": "Cedric Gil Jardine"
    },
    {
      "affiliations": [
        "Emergency department, University Hospital Centre Strasbourg, Strasbourg, France",
        "Nanomédecine regénérative, UMR 1260, Université de Strasbourg CRBS, UNISTRA, Strasbourg, France"
      ],
      "name": "Pierrick Le Borgne"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, CHU de Poitiers, Poitiers, France"
      ],
      "name": "Nicolas Marjanovic"
    },
    {
      "affiliations": [
        "CHU de Besançon, Besancon, France"
      ],
      "name": "Tania Marx"
    },
    {
      "affiliations": [
        "Radiology unit, University Hospitals Strasbourg, Strasbourg, France"
      ],
      "name": "Mickaël Ohana"
    },
    {
      "affiliations": [
        "Emergency Department Saint Louis, AP-HP, Paris, France"
      ],
      "name": "Olivier Peyrony"
    },
    {
      "affiliations": [
        "Department of Emergency, Hopital Pitié-Salpêtrière, Paris, France"
      ],
      "name": "Anne-Laure Philippon"
    },
    {
      "affiliations": [
        "Department of Emergency, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France",
        "Grenoble-Alpes University Hospital, Grenoble, France"
      ],
      "name": "Damien Viglino"
    },
    {
      "affiliations": [
        "Emergency department, University Hospital Centre Strasbourg, Strasbourg, France"
      ],
      "name": "Aline Chenou"
    },
    {
      "affiliations": [
        "Emergency department, University Hospital Centre Strasbourg, Strasbourg, France"
      ],
      "name": "Raphael Clere-Jehl"
    },
    {
      "affiliations": [
        "Emergency department, University Hospital Centre Strasbourg, Strasbourg, France"
      ],
      "name": "Pascal Bilbault"
    },
    {
      "affiliations": [
        "URCEco, AP-HP, Paris, France",
        "University of Paris, Paris, France"
      ],
      "name": "Isabelle Durand-Zaleski"
    },
    {
      "affiliations": [
        "ICube, Illkirch, Grand Est, France",
        "GMRC, University Hospital Centre Strasbourg, Strasbourg, France"
      ],
      "name": "Erik André Sauleau"
    }
  ],
  "title": "Ambulatory management of primary spontaneous pneumothorax in the emergency department: EFFI-PNO protocol – a multicentre, cluster-controlled, stepped-wedge, randomised interventional study",
  "uid": "6e9e211e-75a5-5252-ab04-821008f6da98"
}