{
  "abstract": "Introduction Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.Methods and analysis The SONG trial (NCT 05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.Ethics and dissemination This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.Trial registration number NCT05915663.",
  "authors": [
    {
      "affiliations": [
        "Service de Réanimation Polyvalente, Centre Hospitalier du Mans, Le Mans, France"
      ],
      "name": "Josselin Saletes"
    },
    {
      "affiliations": [
        "Service de Réanimation Polyvalente, Centre Hospitalier du Mans, Le Mans, France"
      ],
      "name": "Christophe Guitton"
    },
    {
      "affiliations": [
        "Unité de Soins Longue Durée, Centre Hospitalier du Mans, Le Mans, France"
      ],
      "name": "Julie Valleroy"
    },
    {
      "affiliations": [
        "Service de Réanimation Polyvalente, Centre Hospitalier du Mans, Le Mans, France"
      ],
      "name": "Severine Guillarme"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire d’Angers, Angers, France"
      ],
      "name": "Carole Haubertin"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Tours, Tours, France"
      ],
      "name": "Gregory Paris"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire d’Orléans, Orléans, France"
      ],
      "name": "Lucie Muller"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Départemental de la Roche-sur-Yon, la Roche-sur-Yon, France"
      ],
      "name": "Cécile Rousseau"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Grenoble, Grenoble, France"
      ],
      "name": "Prescilla Gamon"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Régional Universitaire de Strasbourg, Strasbourg, France"
      ],
      "name": "Sylvie L’Hotellier"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Hôpital Nord, Marseille, France"
      ],
      "name": "Jean-Marie Forel"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, France"
      ],
      "name": "Catherine Roussel"
    },
    {
      "affiliations": [
        "Service de Réanimation Médico-Chirurgicale, Centre Hospitalier de Saint-Nazaire, Saint-Nazaire, France"
      ],
      "name": "Antoine Garin"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Poitiers, Poitiers, France"
      ],
      "name": "Célina Morand"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Saint Antoine, Paris, France"
      ],
      "name": "Eric Maury"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Rennes, Rennes, France"
      ],
      "name": "Nathanael Mangeard"
    },
    {
      "affiliations": [
        "Service de Réanimation Polyvalente, Centre Hospitalier de Cholet, Cholet, France"
      ],
      "name": "Laetitia Menard"
    },
    {
      "affiliations": [
        "Service de Réanimation Polyvalente, Centre Hospitalier de Toulon, Toulon, France"
      ],
      "name": "Pierre-Yves Arnaud"
    },
    {
      "affiliations": [
        "Service de Réanimation Polyvalente, Centre Hospitalier de Périgueux, Périgueux, France"
      ],
      "name": "Aurélie Lejeune"
    },
    {
      "affiliations": [
        "Clinical Research Platform, Centre Hospitalier du Mans, Le Mans, France"
      ],
      "name": "Eglantine Rouanet"
    },
    {
      "affiliations": [
        "Service de Réanimation Polyvalente, Centre Hospitalier du Mans, Le Mans, France"
      ],
      "name": "Jean-Christophe Callahan"
    }
  ],
  "title": "Effect of nasogastric versus orogastric tube placement on ventilator-associated pneumonia incidence in critically ill patients: a study protocol for a cluster randomised crossover trial in 16 intensive care units in France (SONG trial)",
  "uid": "516f5764-511c-59a1-b2a5-c1a4c99da53f"
}