NIH Clinical Research Studies

Protocol Number: 04-CC-0130

Active Followup, Protocols NOT Recruiting New Patients

Title:
The Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients
Number:
04-CC-0130
Summary:
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.

Sponsoring Institute:
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions:
Currently Not Provided
Keyword(s):
Oral Care
ICU
Pneumonia
Pathogens
Intubation
Intubated
Oral Hygiene
Intensive Care
Recruitment Keyword(s):
Oral Care
Condition(s):
Critical Illness
Investigational Drug(s):
None
Investigational Device(s):
None
Interventions:
Behavioral: Oral Care
Supporting Site:
NIH Clinical Center

Contact(s):
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):
Collard HR, Saint S, Matthay MA. Prevention of ventilator-associated pneumonia: an evidence-based systematic review. Ann Intern Med. 2003 Mar 18;138(6):494-501. Review.

Valles J, Mesalles E, Mariscal D, del Mar Fernandez M, Pena R, Jimenez JL, Rello J. A 7-year study of severe hospital-acquired pneumonia requiring ICU admission. Intensive Care Med. 2003 Nov;29(11):1981-8. Epub 2003 Sep 10.

Eggimann P, Hugonnet S, Sax H, Touveneau S, Chevrolet JC, Pittet D. Ventilator-associated pneumonia: caveats for benchmarking. Intensive Care Med. 2003 Nov;29(11):2086-9. Epub 2003 Sep 03.

Active Followup, Protocols NOT Recruiting New Patients

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