Prehospital Ventilator-Associated Pneumonia Prevention Trial

Respiratory Failure Clinical Trial

— P-VAPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902446
• Other study ID #: 201304766
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: June 7, 2017
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Failure
• Respiratory Insufficiency
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Nicholas M Mohr

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pulmonary Infection Score (CPIS)		48-72 hours
Secondary	Pneumonia - CPIS	This is the diagnosis of pneumonia within the first 5 days defined by CPIS score >=6.	5 days
Secondary	Pneumonia - CDC	This is the diagnosis of pneumonia using CDC criteria within 5 days of admission.	5 days
Secondary	Pneumonia - Treated	This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician.	5 days
Secondary	Pneumonia - Research	This is the diagnosis of pneumonia within 5 days as adjudicated by 3 clinicians blinded to treatment allocation.	5 days
Secondary	28-day ventilator-free days		28 days
Secondary	28-day ICU-free days		28 days
Secondary	Hospital Mortality		28-days
Secondary	Tracheostomy Rate		28 days
Secondary	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