Prehospital Ventilator-Associated Pneumonia Prevention Trial

Study Overview
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Brief Summary
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Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural patients from their urban counterparts. Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing hospital stay, healthcare costs, and even mortality in the critically injured. The investigators propose a pilot study to test the hypothesis that a single dose of oral chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy in intensive care units to prevent airway colonization and subsequent development of VAP. Demonstrating safety and effectiveness of prehospital infection control practices could significantly improve outcomes of traumatic injury in rural America.

Official Title
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A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients

Conditions
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Wounds and Injuries, Respiratory Failure, Pneumonia, Ventilator-Associated

Intervention / Treatment
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* Drug: Chlorhexidine gluconate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (age >= 18 years) Endotracheal intubation Transported by air ambulance Traumatic injury Interfacility transport (no flights from scene) en route to University of Iowa Hospitals and Clinics) Exclusion Criteria: Known or suspected pregnancy Prisoners Patients diagnosed with pneumonia prior to transfer Known allergy to chlorhexidine gluconate Surgical airway (tracheostomy or cricothyroidotomy) Massive aspiration Anticipated nonsurvivable injury (survival projected < 24 hours)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chlorhexidine gluconate<br>Intubated subjects transported by one air service will be treated with 5 mL chlorhexidine gluconate 0.12% applied for at least 30 seconds during helicopter transport. | Drug: Chlorhexidine gluconate<br>* Study solution will be applied to the oropharynx and will be distributed for 15 seconds with a swab stick. No suction will be applied for at least 30 seconds.<br>* Other names: PerioGard;|
| Normal saline (placebo)<br>Intubated subjects assigned transported by another air service will not have any additional treatment (in addition to usual care) during helicopter transport. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pulmonary Infection Score (CPIS) |  | 48-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia - CPIS | This is the diagnosis of pneumonia within the first 5 days defined by CPIS score >=6. | 5 days | 
| Pneumonia - CDC | This is the diagnosis of pneumonia using CDC criteria within 5 days of admission. | 5 days | 
| Pneumonia - Treated | This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician. | 5 days | 
| Pneumonia - Research | This is the diagnosis of pneumonia within 5 days as adjudicated by 3 clinicians blinded to treatment allocation. | 5 days | 
| 28-day ventilator-free days |  | 28 days | 
| 28-day ICU-free days |  | 28 days | 
| Hospital Mortality |  | 28-days | 
| Tracheostomy Rate |  | 28 days | 
| Tracheal colonization | This analysis will be completed in two ways: the raw analysis will use a chi-squared test to test the null hypothesis that the distribution of semi-quantitative tracheal colonization is the same in the two groups. A second analysis will be performed using the ordinal shift method to compare the change (shift) in the semiquantitative score between admission and 48-72 hours. | 48-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine, Randomized Controlled Trial, Emergency Medical Services, Intubation, Endotracheal