• Philippe Seguin, Bruno Laviolle, Claire Dahyot-Fizelier, Romain Dumont, Benoit Veber, Soizic Gergaud, Karim Asehnoune, Olivier Mimoz, Pierre-Yves Donnio, Eric Bellissant, Yannick Malledant, Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study Group, and AtlanRéa Group.
• 1Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire, Rennes, France. 2Inserm U991, Rennes, France. 3Université Rennes 1, Rennes, France. 4Service de Pharmacologie, Centre Hospitalier Universitaire, Rennes, France. 5Centre d'Investigation Clinique, Inserm 0203, Rennes, France. 6Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire, Poitiers, France. 7Inserm Eri 23, Poitiers, France. 8Université Poitiers, Poitiers, France. 9Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire, Nantes, France. 10Département d'Anesthésie Réanimation, Réanimation Chirurgicale, Centre Hospitalier Universitaire, Rouen, France. 11Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire, Angers, France. 12Service de Bactériologie-Hygiène, Centre Hospitalier Universitaire, Rennes, France. 13EA 1254 Microbiologie-Risques Infectieux, Université de Rennes 1, Rennes, France.
• Crit. Care Med. 2014 Jan 1; 42 (1): 1-8.

ObjectiveTo evaluate the efficacy and safety of oral care with povidone-iodine on the occurrence of ventilator-associated pneumonia in a high-risk population.DesignA multicenter, placebo-controlled, randomized, double-blind, two-parallel-group trial performed between May 2008 and May 2011.SettingSix ICUs in France.PatientsOne hundred seventy-nine severely brain-injured patients (Glasgow Coma Scale ≤ 8) or cerebral hemorrhage expected to be mechanically ventilated for more than 24 hours.InterventionsParticipants were randomly assigned to receive oropharyngeal care with povidone-iodine (n = 91) or placebo (n = 88) six times daily until mechanical ventilation withdrawal.Measurements And Main ResultsPrimary endpoint was the rate of ventilator-associated pneumonia. Secondary endpoint included the rates of ventilator-associated tracheobronchitis and acute respiratory distress syndrome and patient's outcome. The number of patients evaluable for the primary endpoint (preplanned modified intention-to-treat population) was 150 (78 in the povidone-iodine group, 72 in the placebo group). Ventilator-associated pneumonia occurred in 24 patients (31%) in the povidone-iodine group and 20 (28%) in the placebo group (relative risk, 1.11 [95% CI, 0.67-1.82]; p = 0.69). There was no significant difference between the two groups for ventilator-associated tracheobronchitis: eight patients (10%) in the povidone-iodine group and five patients (7%) in the placebo group (relative risk, 1.48 [95% CI, 0.51-4.31]; p = 0.47). Acute respiratory distress syndrome occurred in five patients in the povidone-iodine group but not in the placebo group (p = 0.06). There was no difference between groups for ICU and hospital lengths of stay, as well as ICU and 90-day mortality.ConclusionsThere is no evidence to recommend oral care with povidone-iodine to prevent ventilator-associated pneumonia in high-risk patients. Furthermore, this strategy seems to increase the rate of acute respiratory distress syndrome.

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