PneumoniaEarly Phase 1VAPNCT00604916
Oral Care Protocol for Preventing Ventilator- Associated Pneumonia
A Early Phase 1 study testing standardized oral care protocol - electronic toothbrush and mimic protocol in people with Pneumonia, run by Mackay Memorial Hospital.
Trial summary
The Nosocomial Pneumonia remains to be a major complication for patients who were incubated with ventilation. Most cases are attributed to increased bacteria flora in oropharyngeal secretion and aspiration of those organisms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- standardized oral care protocol - electronic toothbrush and mimic protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Jan 2008
- Phase
- Early Phase 1
- 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
- Patients newly admitted to SICU who were under ventilator support for 48~72 hours
Who cannot join
- With pneumonia present
About this study
Official title: The Effectiveness of an Oral Care Protocol in Preventing Ventilator- Associated Pneumonia for Intensive Care Unit Patient
The Nosocomial Pneumonia remains to be a major complication for patients who were incubated with ventilation. Most cases are attributed to increased bacteria flora in oropharyngeal secretion and aspiration of those organisms. Research indicates that the Gram-Negative Bacteria grows in upper air way and trachea rapidly during the initial 2-4 hospital days and the dental plague also increased dramatically at the first 5 days. About 50% cases with prolonged intubation experienced temporal swallowing disorders and majority of them recovered 7 days post weaning. Some evidence exist suggesting that oral care could reduce bacterial flora, prevent aspiration, and subsequently decrease the incidence of ventilation-associated pneumonia for this group of high risk patients.
This study aims to evaluate the effectiveness of a standardized oral care protocol in improving oral hygiene and reducing the incidence of pneumonia on a sample of surgical patients at intensive care unit.
- Conditions
- Pneumonia
- Being tested
- standardized oral care protocol - electronic toothbrush, mimic protocol
- Keywords
- oral hygiene
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized oral care protocol - electronic toothbrushOther
a standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily.
mimic protocolOther
a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.
| Study group | Role | What they receive |
|---|---|---|
| E | Experimental | received a 7 day standardized oral care protocol Receives: Other: standardized oral care protocol - electronic toothbrush |
| C | Placebo comparator | received a 7 day mimic protocol Receives: Other: mimic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the oral hygiene status measured by the oral assessment guide and plague index
Measured: every 3~4days
Secondary outcomes (1)
The incidence of VAP defined by the Clinical Pulmonary Infection Score
Measured: a 7 day oral care protocol duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startMar 2007
- Primary completionNov 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Investigators
- li-yin YAO, BSN, Principal investigator, School of Nursing, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604916
- Sponsor's protocol ID
- MMH-I-S-402
- Acronym
- VAP
- Status last verified
- Jan 2008
- First submitted
- 7 Jan 2008
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Oral Care Protocol in Preventing Ventilator- Associated Pneumonia for Intensive Care Unit Patient
- ClinicalTrials.gov ID
- NCT00604916
- Acronym / sponsor ID
- VAP / MMH-I-S-402
- Conditions
- Pneumonia
- Keywords
- oral hygiene
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- Mar 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 30 Jan 2008 (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 Nosocomial Pneumonia remains to be a major complication for patients who were incubated with ventilation. Most cases are attributed to increased bacteria flora in oropharyngeal secretion and aspiration of those organisms. Research indicates that the Gram-Negative Bacteria grows in upper air way and trachea rapidly during the initial 2-4 hospital days and the dental plague also increased dramatically at the first 5 days. About 50% cases with prolonged intubation experienced temporal swallowing disorders and majority of them recovered 7 days post weaning. Some evidence exist suggesting that oral care could reduce bacterial flora, prevent aspiration, and subsequently decrease the incidence of ventilation-associated pneumonia for this group of high risk patients.
This study aims to evaluate the effectiveness of a standardized oral care protocol in improving oral hygiene and reducing the incidence of pneumonia on a sample of surgical patients at intensive care unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E | Experimental | Other: standardized oral care protocol - electronic toothbrushreceived a 7 day standardized oral care protocol |
| C | Placebo comparator | Other: mimic protocolreceived a 7 day mimic protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients newly admitted to SICU who were under ventilator support for 48~72 hours
Key exclusion criteria (1 listed)
- With pneumonia present
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 |
|---|---|---|
| standardized oral care protocol - electronic toothbrusha standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily. | Other | E |
| mimic protocola mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals. | Other | C |
Primary outcome
the oral hygiene status measured by the oral assessment guide and plague index
Time frame: every 3~4days
1 secondary outcome
The incidence of VAP defined by the Clinical Pulmonary Infection Score
Time frame: a 7 day oral care protocol duration
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 30 Jan 2008.
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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.
li-yin YAO, BSN principal investigator
School of Nursing, National Taiwan University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing standardized oral care protocol - electronic toothbrush and mimic protocol in people with Pneumonia, run by Mackay Memorial Hospital.
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 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
the oral hygiene status measured by the oral assessment guide and plague index (time frame: every 3~4days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2008.