Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

NCT ID: NCT00842478

Last Updated: 2009-02-12

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Brief Summary

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

Poor oral hygiene is associated with respiratory pathogen colonization and secondary lung infection.The possible association between oral care and incidence of VAP, and the role of dental plaque, mouth and tracheal colonization have not been firmly established. The investigators' hypothesis was that improving oral care with electrical toothbrushing might be effective in reducing the incidence of VAP.

Detailed Description

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

Conditions

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

Ventilator-Associated Pneumonia Nosocomial Pneumonia 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

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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

Raspall

Group Type EXPERIMENTAL

Toothbrushing

Intervention Type PROCEDURE

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Toothbrushing

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Adult intubated patients
* Without evidence of pulmonary infection (randomized within 12h of intubation if they were expected to remain ventilated for longer than 48 hours)

Exclusion Criteria

* Absence of dental pieces
* Current diagnosis of pneumonia or massive bronchoaspiration
* Tracheostomy (or expected within 48 hours)
* Chlorhexidine allergy
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.

Hospital Universitari Joan XXIII de Tarragona.

OTHER

Sponsor Role lead

Responsible Party

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

Hospital Universitari Joan XXIII

Principal Investigators

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

Jordi Rello, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Joan XXIII

Locations

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

ICU, Hospital Universitari Joan XXIII

Tarragona, Tarragona, Spain

Site Status RECRUITING

Countries

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

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Angel Pobo, MD

Role: CONTACT

34 977 295818

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Angel Pobo, MD

Role: primary

34 977295818

References

Explore related publications, articles, or registry entries linked to this study.

Pobo A, Lisboa T, Rodriguez A, Sole R, Magret M, Trefler S, Gomez F, Rello J; RASPALL Study Investigators. A randomized trial of dental brushing for preventing ventilator-associated pneumonia. Chest. 2009 Aug;136(2):433-439. doi: 10.1378/chest.09-0706. Epub 2009 May 29.

Reference Type DERIVED
PMID: 19482956 (View on PubMed)

Other Identifiers

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

FIS 06/0060

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.