Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit

Study Overview
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Brief Summary
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Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.

Official Title
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Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Drug: povidone iodine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults > 18 years Closed head trauma with a Glasgow Coma Score <=8 or cerebral Hemorrhage with a Glasgow Coma Score of <=8 Expected need mechanical ventilation for >=2 days Written informed consent from the patient's next-of-kin. If no relative is present at the time of inclusion, the patients will be included according to the emergency procedure Exclusion Criteria: Impossibility to perform oropharyngeal decontamination within 12 h following the initial episode Facial injury with impossibility to perform the oropharyngeal decontamination Tetraplegia Known history of reaction to iodine Respiratory disease or pulmonary infiltrate(s) at inclusion Need for curative antibiotics Mercurial antiseptics treatment Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: povidone iodine<br>Povidone iodine | Drug: povidone iodine<br>* oropharyngeal decontamination every 4 hours<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* oropharyngeal decontamination every 4 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ventilator associated pneumonia |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ventilator associated pneumoniae |  | 30 days | 
| Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae |  | 30 days | 
| Length of mechanical ventilation |  | 30 days | 
| Other infections |  | 30 days | 
| Acute respiratory distress syndrome |  | 30 days | 
| Treatments administered (antibiotics, sedatives, transfusion) |  | 30 days | 
| Length of ICU and hospital stay |  | Hospital discharge | 
| Death |  | ICU, 1 months, 3 months | 
| Oropharyngeal bacterial colonisation |  | 30 days | 
| Type of anesthetic agents received |  | 30 days | 
| Rate of tracheostomy |  | 30 days | 
| Rate of transfusion (red blood cells, platelets, plasma) |  | 30 days |