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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00950027

Acronym

SPIRIT-ICU

Enrollment

179

Registered

2009-07-31

Start date

2008-04-30

Completion date

2011-09-30

Last updated

2012-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Brief summary

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.

Interventions

DRUGpovidone iodine

oropharyngeal decontamination every 4 hours

DRUGPlacebo

oropharyngeal decontamination every 4 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of ventilator associated pneumonia	30 days

Secondary

Measure	Time frame
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
Time to ventilator associated pneumoniae	30 days
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
Length of ICU and hospital stay	Hospital discharge

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026