Oral Care to Reduce Mouth and Throat Infections in Critically Ill Patients



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2004
End Date:August 2011

Use our guide to learn which trials are right for you!

The Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients

This study will evaluate whether a program of systematic oral care can help prevent
hospital-acquired respiratory infections in patients in intensive care units. Such
infections occur five times more often in critically ill patients compared with patients in
general hospital wards and result in longer hospital stays and an increased risk of death.
The rate of respiratory infection among critically ill patients correlates strongly with the
presence of disease-causing bacteria in the mucosal areas of the mouth, gums, and teeth,
indicating that assiduous oral care is especially important in this patient population. This
study will compare a program of meticulous oral care using oral assessments taught by a
dentist and dental hygienist with the standard care typically given in intensive care units.

Critically ill patients 18 years of age and older who are hospitalized in an intensive care
unit for 3 or more days and whose oral hygiene is dependent on hospital care providers may
be eligible for this study. Patients will be recruited from intensive care units at four
Washington, D.C., area hospitals - Suburban Hospital, Washington Hospital Center, Inova
Fairfax Hospital, and Winchester Medical Center.

Participants will have their lips, mouth, gums, teeth, and saliva examined several times a
day to determine their optimum oral care. They will receive standard care, such as flossing,
brushing, rinsing with a mouthwash, and possibly use of an antiseptic spray that prevents
bacteria from clinging to the teeth. Small samples of saliva (less than one-fourth of a
teaspoon) and dental plaque will be collected the day the patient is admitted to the
intensive care unit and again on days 3 and 5 of their stay in the unit. The saliva sample
is collected with a small suction tube placed in the corner of the mouth; the plaque
specimen is collected by gliding a tiny piece of paper over the surface of a front tooth.
The samples will be examined for any bacteria not normally found in saliva.

Critically ill patients, especially those that require endotracheal intubation, have the
greatest risk of any hospitalized patient for acquiring nosocomial pneumonia. Nosocomial
pneumonia, in this population, produces a substantial increase of mortality and morbidity.
The literature suggests the causative pathway is aspiration of oropharyngeal pathogens found
in dental plaque. The build-up of dental plaque has been significantly associated with
subsequent nosocomial respiratory infections. Thus, prevention of pathogens colonization in
the oropharyngeal cavity could be an effective infection control measure.

Dental plaque once it reaches a critical thickness, acts as a reservoir for both aerobic and
anaerobic pathogens. Failure to remove plaque begins a complex cascade of biological
activity by which pathogens adhere to mucosal and tooth surfaces and pathogen overgrowth
ensues. Additionally, neglected or insufficient mouth care is the foremost predisposing
factor to oral conditions such as gingivitis, mucositis, and stomatitis which supply
additional ports of entry for pathogens.

There are only a handful of studies that compare the frequency and type of oral hygiene
required to prevent or decrease oropharyngeal colonization. A recent pilot study,
01-CC-0207, compared oral care provision in two intensive care units (ICU) in the Clinical
Center. The test ICU offered meticulous oral hygiene through a system of regular oral
assessments taught by a dentist and dental hygienist. The score from the assessment
determined the type and frequency of oral care. The control ICU gave standard care typical
of the ICU community. Plaque and saliva assays were collected from the enrolled patients.
Significantly lower Beck scores and lower colony forming organisms in the specimens was
achieved in the test ICU on day 3, p less than 0.03 and p less than 0.001 respectively.

This protocol will expand the pilot into a prospective randomized assigned trial conducted
at four hospitals in the Washington D.C. area. These hospitals have ICUs more representative
of ICU's nation-wide. This study will test the effectiveness of a comprehensive and
systematic oral care program to reduce the oral assessment scores, mucosal plaque scores,
and the amount of pathogen inoculum present in the saliva and plaque. Intubated and
non-intubated patients will be compared as well as meticulous care with or without the
addition of the oral antiseptic, chlorhexidine. Consistency of practice performance will
also be evaluated when nursing staff has dentist/hygienist instruction and monitoring versus
the traditional nurse instruction.

- INCLUSION CRITERIA:

- Male or female adult ICU patients whose oral hygiene is dependent upon hospital care
providers.

- Expected length of ICU stay is greater than or equal to 3 days.

- Any gender and ethnicity.

EXCLUSION CRITERIA:

- Individuals and or responsible family members who are unable to provide consent.

- Any individual under the age of 18 years.

- Any individual whose expected admission is less than 3 days.

- Adult ICU patients whose admission CPIS score is greater than 6.

- Individuals who are able to provide own oral care.

- Individuals who have oral surgery that requires specialized oral care and assessment.

- Edentulous patients.

- Any patient with a prosthetic heart valve or who routinely takes prophylactic
antibiotics before routine dental procedures.

- Any patient with a known allergy to chlorhexidine.
We found this trial at
5
sites
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
?
mi
from
Washington,
Click here to add this to my saved trials
Winchester, Virginia 22604
?
mi
from
Winchester, VA
Click here to add this to my saved trials