Ventilator Associated PneumoniaPhase 4NCT01477099
Toothbrushing and Ventilator-associated Pneumonia
A Phase 4 study testing Toothbrushing with a manual brush in people with Ventilator Associated Pneumonia, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Toothbrushing with a manual brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2010to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanical ventilation
Who cannot join
- edentulous
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Toothbrushing for the Prevention of Ventilator-associated Pneumonia
The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Toothbrushing with a manual brush
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothbrushing with a manual brushDevice
Toothbrushing with a manual brush
| Study group | Role | What they receive |
|---|---|---|
| Toothbrushing with a manual brush | Experimental | Toothbrushing with a manual brush Receives: Device: Toothbrushing with a manual brush |
| No toothbrushing | No intervention | no toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of ventilator-associated pneumonia
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Cervino, Hospital Universitario de Canarias
- Investigators
- Leonardo Lorente, Medical, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477099
- Sponsor's protocol ID
- BRUSH-2009
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lorente L, Lecuona M, Jimenez A, Palmero S, Pastor E, Lafuente N, Ramos MJ, Mora ML, Sierra A. Ventilator-associated pneumonia with or without toothbrushing: a randomized controlled trial. Eur J Clin Microbiol Infect Dis. 2012 Oct;31(10):2621-9. doi: 10.1007/s10096-012-1605-y. Epub 2012 Mar 16.
PubMed 22422274
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Toothbrushing for the Prevention of Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT01477099
- Acronym / sponsor ID
- BRUSH-2009
- Conditions
- Ventilator Associated Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothbrushing with a manual brush | Experimental | Device: Toothbrushing with a manual brushToothbrushing with a manual brush |
| No toothbrushing | No intervention | –no toothbrushing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mechanical ventilation
Key exclusion criteria (1 listed)
- edentulous
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothbrushing with a manual brushToothbrushing with a manual brush | Device | Toothbrushing with a manual brush |
Primary outcome
Prevention of ventilator-associated pneumonia
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Derived from this study: PubMed 22422274Lorente L, Lecuona M, Jimenez A, Palmero S, Pastor E, Lafuente N, Ramos MJ, Mora ML, Sierra A. Ventilator-associated pneumonia with or without toothbrushing: a randomized controlled trial. Eur J Clin Microbiol Infect Dis. 2012 Oct;31(10):2621-9. doi: 10.1007/s10096-012-1605-y. Epub 2012 Mar 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo Lorente, Medical principal investigator
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Toothbrushing with a manual brush in people with Ventilator Associated Pneumonia, run by Hospital Universitario de Canarias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of ventilator-associated pneumonia (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.