MedDataX Logo

Strategies to Prevent Pneumonia (SToP Pneumonia)

NCT ID: NCT00234598

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

547 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventilator Associated Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group, usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Tooth brushing only

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

Group Type ACTIVE_COMPARATOR

Toothbrushing only

Intervention Type PROCEDURE

Toothbrushing three times per 24 hours without chlorhexidine

Chlorhexidine only

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine only

Intervention Type PROCEDURE

Chlorhexidine oral rinse twice per 24 hours without toothbrushing

Toothbrushing and chlorhexidine

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)

Group Type ACTIVE_COMPARATOR

Toothbrushing and Chlorhexidine

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Toothbrushing only

Toothbrushing three times per 24 hours without chlorhexidine

Intervention Type PROCEDURE

Chlorhexidine only

Chlorhexidine oral rinse twice per 24 hours without toothbrushing

Intervention Type PROCEDURE

Toothbrushing and Chlorhexidine

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cindy Munro, RN, ANP,PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01NR007652

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01 NR07652 (NIH)

Identifier Type: -

Identifier Source: secondary_id

VCU1006

Identifier Type: -

Identifier Source: org_study_id