Ventilator Associated PneumoniaPhase 1NCT01083407
Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children
A Phase 1 study testing 0.12% Chlorhexidine Digluconate and Toothbrushing in people with Ventilator Associated Pneumonia, run by Federal University of São Paulo.
Trial summary
This experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection begun in April, 2005 during the performance of the masters degree course dissertation entitled "Clinical study about the effect of the… Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- 0.12% Chlorhexidine Digluconate and Toothbrushing
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Jun 2008
- Phase
- 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 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Critically ill children.
- Age: 29 days to 18 years.
Who cannot join
- Newborn age.
- Pneumonia at PICU admission.
- Tracheostomy.
- Tracheal intubation higher than 24 hours in the PICU admission.
- PICU LOS lower than 48 hours.
- Responsibles declined consent.
About this study
Official title: Oral Care Interventions With 0.12% Chlorhexidine and Ventilator Associated Pneumonia in Critically Ill Children: Prospective, Randomic and Double Blind Study
This experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection begun in April, 2005 during the performance of the masters degree course dissertation entitled "Clinical study about the effect of the oral hygiene with chlorhexidine digluconate 0.12% in the oropharynx colonization of children in intensive care", being performed in a PICU of nine beds in a university hospital in the city of São Paulo, after approval of the Research Ethics Committee of the institution. The study is composed by three types of variables: Independent variable, dependent variables, and complementary variables. The categorical variables will be analyzed in accordance with the Person's Chi-Square test of or Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or Kruskall Wallis. For variables with heterogeneous distribution between the groups, the multivariate analysis will be applied to the evaluation of the influence in the determination of the development risk of the dependent variable. The rejection level will be fixed in 0.05 of the nullity hypothesis.
Read the detailed description
Recent progress in identification of oral microorganisms has shown that the oropharynx can be a site of origin for dissemination of pathogenic organisms to distant body sites, such as the lungs. THe aims of the study were to compare the oropharyngeal microbiological profile, VAP incidence, duration of mechanical ventilation, and length of stay in the intensive care unit of children receiving mechanical ventilation who had pharmacological or nonpharmacological oral care.
A randomized and controlled study has been performed in a pediatric intensive unit in São Paulo, Brazil. The children are randomly assigned to an experimental group that received oral care with use of 0.12% chlorhexidine digluconate or a control group that received oral care without an antiseptic. Oropharyngeal and tracheal secretions were collected and cultured on days 0, 2, and 4, and at discharge.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- 0.12% Chlorhexidine Digluconate, Toothbrushing
- Keywords
- Oral care., Chlorhexidine., Pediatric Nursing, Intensive Care, Nosocomial infection, Pneumonia, Oropharyngeal colonization, Tracheal colonization
- Medical subject headings
- Pneumonia, Ventilator-Associated, Cross Infection, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% Chlorhexidine DigluconateDrug
Oral care with 0.12% Chlorhexidine Digluconate and toothbrushing is realized twice a day and took about 10 minutes to complete, depending on the child's acceptance and clinical conditions.
ToothbrushingOther
Gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto-anterior movements.
| Study group | Role | What they receive |
|---|---|---|
| 0.12% Chlorhexidie Digluconate | Experimental | Oral care included use of an oral gel containing chlorhexidine digluconate 0.12% as an active ingredient (chlorhexidine digluconate 0.12%; methylcellulose gel 2.12%, 25 g; gooseberry syrup, 4 drops; menthol solution 50%,3 drops; and distilled water, to 30 g).The gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular,lingual, occlusal, and incisal). After each quadrant was cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto- anterior movements. Receives: Drug: 0.12% Chlorhexidine Digluconate |
| Toothbrushing | Placebo comparator | This group received the same oral care that experimental group with the use of a similarly formulated gel without the antiseptic agent.The gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto-anterior movements. Receives: Other: Toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator associated pneumonia
Influence of oral care with 0.12% chlorhexidine on VAP incidence diagnosed by clinical pulmonary infection score.
Measured: 48 hours after tracheal intubation
Secondary outcomes (2)
PICU Lengh of Stay
Influence of oral care with 0.12% chlorhexidine on PICU LOS
Measured: Necessary days to PICU discharge
Time of Mechanical pulmonary ventilation
Influence of oral care with 0.12% chlorhexidine on time of mechanical ventilation.
Measured: Last day of MPV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJun 2005
- Primary completionJun 2006
- Study completionJun 2008
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083407
- Sponsor's protocol ID
- Oral care and VAP in children.
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2010
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kusahara DM, Friedlander LT, Peterlini MA, Pedreira ML. Oral care and oropharyngeal and tracheal colonization by Gram-negative pathogens in children. Nurs Crit Care. 2012 May-Jun;17(3):115-22. doi: 10.1111/j.1478-5153.2012.00494.x. Epub 2012 Feb 23.
PubMed 22497915
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care Interventions With 0.12% Chlorhexidine and Ventilator Associated Pneumonia in Critically Ill Children: Prospective, Randomic and Double Blind Study
- ClinicalTrials.gov ID
- NCT01083407
- Acronym / sponsor ID
- Oral care and VAP in children.
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Oral care., Chlorhexidine., Pediatric Nursing, Intensive Care, Nosocomial infection, Pneumonia, Oropharyngeal colonization, Tracheal colonization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Mar 2010 (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.
This experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection begun in April, 2005 during the performance of the masters degree course dissertation entitled "Clinical study about the effect of the oral hygiene with chlorhexidine digluconate 0.12% in the oropharynx colonization of children in intensive care", being performed in a PICU of nine beds in a university hospital in the city of São Paulo, after approval of the Research Ethics Committee of the institution. The study is composed by three types of variables: Independent variable, dependent variables, and complementary variables. The categorical variables will be analyzed in accordance with the Person's Chi-Square test of or Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or Kruskall Wallis. For variables with heterogeneous distribution between the groups, the multivariate analysis will be applied to the evaluation of the influence in the determination of the development risk of the dependent variable. The rejection level will be fixed in 0.05 of the nullity hypothesis.
Detailed description
Recent progress in identification of oral microorganisms has shown that the oropharynx can be a site of origin for dissemination of pathogenic organisms to distant body sites, such as the lungs. THe aims of the study were to compare the oropharyngeal microbiological profile, VAP incidence, duration of mechanical ventilation, and length of stay in the intensive care unit of children receiving mechanical ventilation who had pharmacological or nonpharmacological oral care.
A randomized and controlled study has been performed in a pediatric intensive unit in São Paulo, Brazil. The children are randomly assigned to an experimental group that received oral care with use of 0.12% chlorhexidine digluconate or a control group that received oral care without an antiseptic. Oropharyngeal and tracheal secretions were collected and cultured on days 0, 2, and 4, and at discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.12% Chlorhexidie Digluconate | Experimental | Drug: 0.12% Chlorhexidine DigluconateOral care included use of an oral gel containing chlorhexidine digluconate 0.12% as an active ingredient (chlorhexidine digluconate 0.12%; methylcellulose gel 2.12%, 25 g; gooseberry syrup, 4 drops; menthol solution 50%,3 drops; and distilled water, to 30 g).The gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular,lingual, occlusal, and incisal). After each quadrant was cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto- anterior movements. |
| Toothbrushing | Placebo comparator | Other: ToothbrushingThis group received the same oral care that experimental group with the use of a similarly formulated gel without the antiseptic agent.The gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto-anterior movements. |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Critically ill children.
- Age: 29 days to 18 years.
Key exclusion criteria (6 listed)
- Newborn age.
- Pneumonia at PICU admission.
- Tracheostomy.
- Tracheal intubation higher than 24 hours in the PICU admission.
- PICU LOS lower than 48 hours.
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 |
|---|---|---|
| 0.12% Chlorhexidine DigluconateOral care with 0.12% Chlorhexidine Digluconate and toothbrushing is realized twice a day and took about 10 minutes to complete, depending on the child's acceptance and clinical conditions. | Drug | 0.12% Chlorhexidie Digluconate |
| ToothbrushingGel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto-anterior movements. | Other | Toothbrushing |
Primary outcome
Ventilator associated pneumonia
Time frame: 48 hours after tracheal intubation
Influence of oral care with 0.12% chlorhexidine on VAP incidence diagnosed by clinical pulmonary infection score.
2 secondary outcomes
PICU Lengh of Stay
Time frame: Necessary days to PICU discharge
Time of Mechanical pulmonary ventilation
Time frame: Last day of MPV
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 9 Mar 2010.
- Derived from this study: PubMed 22497915Kusahara DM, Friedlander LT, Peterlini MA, Pedreira ML. Oral care and oropharyngeal and tracheal colonization by Gram-negative pathogens in children. Nurs Crit Care. 2012 May-Jun;17(3):115-22. doi: 10.1111/j.1478-5153.2012.00494.x. Epub 2012 Feb 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.12% Chlorhexidine Digluconate and Toothbrushing in people with Ventilator Associated Pneumonia, run by Federal University of São Paulo.
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 2 inclusion and 6 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 9 Mar 2010. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Ventilator associated pneumonia (time frame: 48 hours after tracheal intubation). 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 NCT01083407, 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 9 Mar 2010.