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| ID | Type | Description | Link |
|---|---|---|---|
| AFSSAPS A70642-35 | Other Identifier | AFSSAPS: French Health Products Safety Agency | |
| Sponsor PHRC/06-05 SPIRIT ICU | Other Identifier | Rennes University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| povidone iodine | Experimental | Povidone iodine |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| povidone iodine | Drug | oropharyngeal decontamination every 4 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ventilator associated pneumonia | 30 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Seguin, MD, PhD | Rennes University Hospital | Principal Investigator |
| Bruno Laviolle, MD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24105456 | Derived | Seguin P, Laviolle B, Dahyot-Fizelier C, Dumont R, Veber B, Gergaud S, Asehnoune K, Mimoz O, Donnio PY, Bellissant E, Malledant Y; Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study Group; AtlanRea Group. 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. Crit Care Med. 2014 Jan;42(1):1-8. doi: 10.1097/CCM.0b013e3182a2770f. |
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| Placebo |
| Drug |
oropharyngeal decontamination every 4 hours |
|
| 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 |
| Nantes |
| France |
| CHU de Poitiers | Poitiers | France |
| Surgical Intensive Care Unit - CHU de Rennes | Rennes | France |
| CHU de Rouen | Rouen | France |
| Réanimation chirurgicale CHU Tours | Tours | France |
| CHG Vannes | Vannes | France |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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