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

NCT00078663 | Completed Phase 3

• 2 other identifiers: 04013004-CC-0130
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Critical Illness

Keywords

Oral Care; ICU; Pneumonia; Pathogens; Intubation; Intubated; Oral Hygiene; Intensive Care

Interventions

Oral Care BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (5)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Inova Fairfax Hospital

Fairfax, Virginia, United States

Location

Winchester Medical Center

Winchester, Virginia, United States

Location

Related Publications (3)

• 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. doi: 10.7326/0003-4819-138-6-200303180-00015.

  PMID: 12639084 BACKGROUND

• 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. doi: 10.1007/s00134-003-2008-4. Epub 2003 Sep 10.

  PMID: 13680109 BACKGROUND

• 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. doi: 10.1007/s00134-003-1991-9. Epub 2003 Sep 3.

  PMID: 12955177 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Pneumonia

Interventions

Dental Care Team

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient Care Team; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 3, 2004
• First Posted: March 4, 2004
• Study Start: March 2, 2004
• Primary Completion: December 28, 2007
• Study Completion: August 16, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-08-16

Locations

US (5)