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Strategies to Prevent Pneumonia (SToP Pneumonia)

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status and phase

Completed
Phase 2

Conditions

Ventilator Associated Pneumonia

Treatments

Procedure: Toothbrushing and Chlorhexidine
Procedure: Chlorhexidine only
Procedure: Toothbrushing only

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00234598
R01NR007652 (U.S. NIH Grant/Contract)
VCU1006
R01 NR07652 (NIH)

Details and patient eligibility

About

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.

Full 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.

Enrollment

547 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

547 participants in 4 patient groups

Control group, usual care
No Intervention group
Description:
Usual care with no study interventions provided; no tooth brushing intervention and no chlorhexidine intervention. Usual care
Tooth brushing only
Active Comparator group
Description:
Tooth brushing by study personnel three times per 24 hours (TID) without chlorhexidine application.
Treatment:
Procedure: Toothbrushing only
Chlorhexidine only
Active Comparator group
Description:
Oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID) without tooth brushing.
Treatment:
Procedure: Chlorhexidine only
Toothbrushing and chlorhexidine
Active Comparator group
Description:
Tooth brushing by study personnel three times per 24 hours (TID) and oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID)
Treatment:
Procedure: Toothbrushing and Chlorhexidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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