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Strategies to Prevent Pneumonia (SToP Pneumonia)

Oral Care Intervention in Mechanically Ventilated Adults

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00234598
Enrollment
547
Registered
2005-10-07
Start date
2002-03-31
Completion date
2008-02-29
Last updated
2015-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

Pneumonia, Dental Health, Critical Care

Brief summary

This study tests whether special oral care provided by nurses to critically ill patients who are on a breathing machine (mechanical ventilator) can help to reduce the build-up of dental plaque on the teeth and reduce the risk of pneumonia.

Detailed description

Pneumonia is the leading cause of death from hospital-acquired infections. Intubation and mechanical ventilation greatly increase the risk of bacterial ventilator associated pneumonia. Growth of potentially pathogenic bacteria in dental plaque of critically ill patients provides a nidus of infection for microorganisms that have been shown to be responsible for the development of Ventilator Associated Pneumonia. Since these organisms are concentrated in dental plaque, removal of organisms from the oral cavity by oral care interventions is a theoretically attractive method to reduce the risk of development of Ventilator Associated Pneumonia. However, evidence-based protocols for oral care of mechanically ventilated patients are not available. Results of the study have the potential to improve nursing care, and to positively affect patient well-being, morbidity, mortality, and health care costs.

Interventions

PROCEDUREToothbrushing only

Toothbrushing three times per 24 hours without chlorhexidine

PROCEDUREChlorhexidine only

Chlorhexidine oral rinse twice per 24 hours without toothbrushing

PROCEDUREToothbrushing and Chlorhexidine

Toothbrushing three times per 24 hours plus chlorhexidine twice per 24 hours.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older, admitted to one of four intensive care units at the study hospital, breathing tube in place, and on a breathing machine (mechanical ventilator)

Exclusion criteria

* Breathing tube in place for more than 24 hours prior to entry into the study, absence of teeth, or a medical diagnosis of pneumonia when the breathing tube is put in.

Design outcomes

Primary

MeasureTime frame
Reduction of build-up of dental plaque on the teeth and reduced risk of pneumonia in critical care patients, as a result of special oral care provided by nurses.7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026