An observational study in Oropharynx Abnormality, Pneumonia, Ventilator-Associated and Chlorhexidine, sponsored by Hôpital Louis Mourier. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by Hôpital Louis Mourier · Observational
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Ventilator-associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most widespread preventive measure to prevent VAP. Precise microbial documentation of CMW efficacy on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in patients' saliva at the same time-points after CMW.
Ventilator associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most widespread preventive measure to prevent VAP. Although many guidelines and expert opinions recommend oral hygiene with chlorhexidine, optimal conditions of CMW use remain unknown. In addition, precise microbial documentation of CMW efficacy on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in the saliva at the same time-points after CMW.
In the participanting unit, CMW is performed every 6 hours with a 0.12% chlorhexidine solution.
Hence, microbial oropharyngeal sampling will be performed 6h after the last CMW (and just before the next one), to assess oropharyngeal colonization and then 15 minutes, 1 hour, 2 hours, 4 hours, and 6 hours after a new CMW to assess CMW efficacy in terms of bacterial growth.
In a subset of patients, 0.5 mL of saliva will be collected with a syringe at the same time points, with an additional T30 time (at 30 minutes) to measure chlorhexidine concentration.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 83 are open to participants now.
This study's enrollment of 30 is below the median of 170 across 132 observational studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Hôpital Louis Mourier is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Non-inclusion criteria:
Exclusion Criteria:
Consecutive critically-ill patients admitted to the ICU and receiving invasive mechanical ventilation for more than 48 hours
changes over time of bacterial growth
oropharyngeal colonization (i.e., amount of bacterial growth in each oropharyngeal sample) before and after a mouth wash with chlorhexidine will be measured at different time points (before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine)
Time frame: 6 hours (360 minutes)
changes over time of bacterial growth of each bacterial specie
changes over time in bacterial growth of each bacterial species isolated in the oropharynx will be measured before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine
Time frame: 6 hours (360 minutes)
susceptibility of isolates to chlorhexidine
chlorhexidine minimal inhibitory concentration of dominant pathogens of each patient will be determined using the broth microdilution method recommended by the Clinical \& Laboratory Standards Institute
Time frame: 1 hour
salivary concentration of chlorhexidine
salivary concentration of chlorhexidine will be measured 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine using high-pressure liquid chromatography
Time frame: 6 hours (360 minutes)
No study locations are listed for this record.
Plan to share: Undecided
Ran from Jan 2014 to primary completion in Mar 2014, 2 months.
Of 63 non-industry observational studies under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 2 months is below that.
Counting every sponsor, half of 63 studies reached it within 20 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Pneumonia, Ventilator-Associated →
Hôpital Louis Mourier