Oral Care to Reduce Mouth and Throat Infections in Critically Ill Patients
Completed · Phase 3
Conditions studied: Critical Illness
In brief
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.
Key facts
- Study ID
- NCT00078663
- Run by
- National Institutes of Health Clinical Center (CC)
- People needed
- 800
- Starts
- 2004-03-02
- Expected to finish
- 2011-08-16
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Washington Hospital Center — Washington D.C., District of Columbia, United States
- Suburban Hospital — Bethesda, Maryland, United States
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- Inova Fairfax Hospital — Fairfax, Virginia, United States
- Winchester Medical Center — Winchester, Virginia, United States
Full record on ClinicalTrials.gov
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