Prehospital Ventilator-Associated Pneumonia Prevention Trial

NCT01902446 | Completed DMC

• 1 other identifier: 201304766
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Chlorhexidine; Randomized Controlled Trial; Emergency Medical Services; Intubation, Endotracheal

Outcome Measures

Primary Outcomes (1)

• Clinical Pulmonary Infection Score (CPIS)

  48-72 hours

Secondary Outcomes (9)

• Pneumonia - CPIS

  5 days

• Pneumonia - CDC

  5 days

• Pneumonia - Treated

  5 days

• Pneumonia - Research

  5 days

• 28-day ventilator-free days

  28 days

Study Arms (2)

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

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.

Interventions

Chlorhexidine gluconate DRUG

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.

Also known as: Peridex, PerioGard

Chlorhexidine gluconate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nicholas M Mohr: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Respiratory Insufficiency; Pneumonia, Ventilator-Associated

Interventions

chlorhexidine gluconate; Chlorhexidine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Nicholas M Mohr, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine and Anesthesia Critical Care

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 9, 2017

Record last verified: 2017-06

Locations

US (1)