Prehospital Ventilator-Associated Pneumonia Prevention Trial (P-VAPP)

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

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Respiratory Failure; Pneumonia, Ventilator-Associated
• Intervention / Treatment: Drug: Chlorhexidine gluconate

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All intubated adult patients transported by air ambulance to the University of Iowa Hospitals and Clinics in interfacility transport after traumatic injury.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chlorhexidine gluconate; 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; 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.; Other Names: Peridex; PerioGard
Normal saline (placebo); 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?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nicholas M Mohr
• Investigators: Principal Investigator: Nicholas M Mohr, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (Estimate): July 18, 2013

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Emergency Medical Services; Randomized Controlled Trial; Chlorhexidine; Intubation, Endotracheal
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Respiratory Insufficiency; Pneumonia; Wounds and Injuries; Pneumonia, Ventilator-Associated; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 201304766