Strategies to Prevent Pneumonia (SToP Pneumonia)

NCT00234598 | Completed Phase 2

• 3 other identifiers: VCU1006R01NR007652R01 NR07652 (NIH)
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Pneumonia; Dental Health; Critical Care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Control group, usual care

NO INTERVENTION

Usual care with no study interventions provided; no tooth brushing intervention and no chlorhexidine intervention. Usual care

Tooth brushing only

ACTIVE COMPARATOR

Tooth brushing by study personnel three times per 24 hours (TID) without chlorhexidine application.

Procedure: Toothbrushing only

Chlorhexidine only

ACTIVE COMPARATOR

Oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID) without tooth brushing.

Procedure: Chlorhexidine only

Toothbrushing and chlorhexidine

ACTIVE COMPARATOR

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)

Procedure: Toothbrushing and Chlorhexidine

Interventions

Toothbrushing only PROCEDURE

Toothbrushing three times per 24 hours without chlorhexidine

Tooth brushing only

Chlorhexidine only PROCEDURE

Chlorhexidine oral rinse twice per 24 hours without toothbrushing

Chlorhexidine only

Toothbrushing and Chlorhexidine PROCEDURE

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

Toothbrushing and chlorhexidine

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia

Interventions

Toothbrushing; Chlorhexidine

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Cindy Munro, RN, ANP,PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 7, 2005
• Study Start: March 1, 2002
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

US (1)