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Effect of Oropharyngeal Povidone-Iodine Preventive Oral Care on Ventilator-Associated Pneumonia in Severely Brain-Injured or Cerebral Hemorrhage Patients: A Multicenter, Randomized Controlled Trial*

Seguin, Philippe MD, PhD1,2,3; Laviolle, Bruno MD, PhD3,4,5; Dahyot-Fizelier, Claire MD, PhD6,7,8; Dumont, Romain MD9; Veber, Benoit MD10; Gergaud, Soizic MD11; Asehnoune, Karim MD, PhD9; Mimoz, Olivier MD, PhD6,7,8; Donnio, Pierre-Yves PharmD12,13; Bellissant, Eric MD, PhD3,4,5; Malledant, Yannick MD1,2,3; for the Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study and AtlanRéa Groups

doi: 10.1097/CCM.0b013e3182a2770f
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Objective: To evaluate the efficacy and safety of oral care with povidone-iodine on the occurrence of ventilator-associated pneumonia in a high-risk population.

Design: A multicenter, placebo-controlled, randomized, double-blind, two-parallel-group trial performed between May 2008 and May 2011.

Setting: Six ICUs in France.

Patients: One hundred seventy-nine severely brain-injured patients (Glasgow Coma Scale ≤ 8) or cerebral hemorrhage expected to be mechanically ventilated for more than 24 hours.

Interventions: Participants 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 Results: Primary 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.

Conclusions: There 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.

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.

* See also p. 188.

Drs. Seguin and Laviolle contributed equally to this study.

Currently listed as ClinicalTrials.gov (NCT00950027).

This work was done in the Département d’Anesthésie Réanimation, Centre Hospitalier Universitaire, Rennes, France; Département d’Anesthésie Réanimation, Centre Hospitalier Universitaire, Poitiers, France; Département d’Anesthésie Réanimation, Centre Hospitalier Universitaire, Nantes, France; Département d’Anesthésie Réanimation, Centre Hospitalier Universitaire, Rouen, France; Département d’Anesthésie Réanimation, Centre Hospitalier Universitaire, Angers, France.

Supported, in part, by a grant from French Ministry of Health (2006, Programme Hospitalier de Recherche Clinique).

Dr. Veber is a board member for Lilly and lectured for Baxter. He received support for travel from Pfizer. Dr. Asehnoune lectured for B-Braun, Fresenius, and Baxter. Dr. Mimoz has received lecture and consultant fees from CareFusion, 3M Company, and Ethicon. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Address requests for reprints to: Philippe Seguin, MD, PhD, Service d’Anesthésie-Réanimation 1, Réanimation Chirurgicale, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux, 35033 Rennes Cedex 9, France. E-mail: philippe.seguin@chu-rennes.fr

© 2014 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins