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NCT00078663 · ClinicalTrials.gov registry record · Phase 3
Oral Care to Reduce Mouth and Throat Infections in Critically Ill Patients
A Phase 3 study of Critical Illness, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
- 5
- Study locations
NCT00078663 is a Phase 3 study of Critical Illness that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 800 participants, below the 3,130-participant average among 91 other Critical Illness trials with a reported enrollment target (74% lower). The trial reports 5 study locations across 3 states.
The verdict
NCT00078663, a Phase 3 study of Critical Illness, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
- 5
- Study locations
Study 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 sa
Conditions Studied
Interventions
- BEHAVIORAL Oral Care
Study Locations (5)
Maryland
- Suburban Hospital - Bethesda
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Virginia
- Inova Fairfax Hospital - Fairfax
- Winchester Medical Center - Winchester
District of Columbia
- Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2004-03-02 |
| Est. Completion | 2011-08-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078663
The ClinicalTrials.gov registry entry for NCT00078663 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,130-participant average among 91 other Critical Illness trials with a reported enrollment target (74% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Critical Illness appearing as the primary indexed condition, and to 1 intervention - of which Oral Care is the first listed.
NCT00078663 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Maryland, Virginia, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00078663 about?
NCT00078663 is a clinical study titled "Oral Care to Reduce Mouth and Throat Infections in Critically Ill 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 long...
What is the current status of trial NCT00078663?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2004-03-02. Estimated completion is 2011-08-16.
What conditions does trial NCT00078663 study?
This clinical trial studies the following conditions: Critical Illness.
What interventions are being tested in trial NCT00078663?
The interventions under investigation include: Oral Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT00078663?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00078663 being conducted?
This trial has 5 study locations across District of Columbia, Maryland, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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