Prehospital Ventilator-Associated Pneumonia Prevention Trial (P-VAPP)
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|ClinicalTrials.gov Identifier: NCT01902446|
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment|
|Wounds and Injuries Respiratory Failure Pneumonia, Ventilator-Associated||Drug: Chlorhexidine gluconate|
|Study Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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.
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.
- Clinical Pulmonary Infection Score (CPIS) [ Time Frame: 48-72 hours ]
- Pneumonia - CPIS [ Time Frame: 5 days ]This is the diagnosis of pneumonia within the first 5 days defined by CPIS score >=6.
- Pneumonia - CDC [ Time Frame: 5 days ]This is the diagnosis of pneumonia using CDC criteria within 5 days of admission.
- Pneumonia - Treated [ Time Frame: 5 days ]This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician.
- Pneumonia - Research [ Time Frame: 5 days ]This is the diagnosis of pneumonia within 5 days as adjudicated by 3 clinicians blinded to treatment allocation.
- 28-day ventilator-free days [ Time Frame: 28 days ]
- 28-day ICU-free days [ Time Frame: 28 days ]
- Hospital Mortality [ Time Frame: 28-days ]
- Tracheostomy Rate [ Time Frame: 28 days ]
- Tracheal colonization [ Time Frame: 48-72 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902446
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Nicholas M Mohr, MD||University of Iowa|