Ventilator Associated PneumoniaNCT01382446
Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma
A study testing Chlorhexidine gluconate and Toothpaste in people with Ventilator Associated Pneumonia, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol for trauma patients on ventilator support to decrease the incidence of Ventilator Associated Pneumonia and oral bacterial load. 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?
- Chlorhexidine gluconate and Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults admitted to ICUs located in Tower Two Critical Care Units: Medical, Surgical, Medical #2, and Trauma Intensive Care Units.
- Patients will be randomized to either treatment or standard group based on day of admission to Intensive Care Units. No limitation regarding gender, race, and ethnicity so that the sample will reflect "typical" Trauma population.
Who cannot join
- All patients admitted under "Doe" Status
- All patients with acute cervical spine injuries or facial fractures that oral care will create further harm to the patient (physician order stating "no oral care to be given" will be in chart)
- All patients with Oral Trauma or Oral Surgery
- All minors (Study will be completed in Adult Critical Care Units)
- Patients with allergy to chlorhexidine
- Patients without Teeth, or with fewer than 6 teeth
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults
Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol for trauma patients on ventilator support to decrease the incidence of Ventilator Associated Pneumonia and oral bacterial load.
Read the detailed description
To see a significant decrease in the bacterial load in the oral mucosa and subsequently, a decrease in the pathogenesis of Ventilator Associated Pneumonia through the use of an oral rinse containing 0.12% Chlorhexidine Gluconate as part of an oral care protocol. Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Chlorhexidine gluconate, Toothpaste
- Keywords
- Trauma, Mechanical Ventilation, Ventilator Associated Pneumonia, Oral Care
- Medical subject headings
- Pneumonia, Ventilator-Associated, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Peridex
0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
ToothpasteOther
Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Standard Oral Care Regimen | Active comparator | Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus. Receives: Other: Toothpaste |
| Chlorhexidine Oral Care Regimen | Experimental | This study will compare our current oral care practice with the use of Chlorhexidine Gluconate 0.12% (Peridex, 3M Corporation) Twice daily in addition to regularly scheduled oral care as a means to decrease the incidence of VAP utilizing evidence-based strategies. Receives: Drug: Chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients
Examination of number of participants who do not develop oral bacteria and Ventilator Associated Pneumonia when an oral rinse containing 0.12% Chlorhexidine Gluconate is used as part of a oral care protocol.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, Madelon Petersen, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Tracy Thomas, MSN, Principal investigator, St. Joseph's Hospital and Medical Center, Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382446
- Sponsor's protocol ID
- IRB#09NU127
- Status last verified
- Dec 2016
- First submitted
- 23 Jun 2011
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults
- ClinicalTrials.gov ID
- NCT01382446
- Acronym / sponsor ID
- IRB#09NU127
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Trauma, Mechanical Ventilation, Ventilator Associated Pneumonia, Oral Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- 3M
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 28 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol for trauma patients on ventilator support to decrease the incidence of Ventilator Associated Pneumonia and oral bacterial load.
Detailed description
To see a significant decrease in the bacterial load in the oral mucosa and subsequently, a decrease in the pathogenesis of Ventilator Associated Pneumonia through the use of an oral rinse containing 0.12% Chlorhexidine Gluconate as part of an oral care protocol. Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Oral Care Regimen | Active comparator | Other: ToothpasteCurrent oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus. |
| Chlorhexidine Oral Care Regimen | Experimental | Drug: Chlorhexidine gluconateThis study will compare our current oral care practice with the use of Chlorhexidine Gluconate 0.12% (Peridex, 3M Corporation) Twice daily in addition to regularly scheduled oral care as a means to decrease the incidence of VAP utilizing evidence-based strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults admitted to ICUs located in Tower Two Critical Care Units: Medical, Surgical, Medical #2, and Trauma Intensive Care Units.
- Patients will be randomized to either treatment or standard group based on day of admission to Intensive Care Units. No limitation regarding gender, race, and ethnicity so that the sample will reflect "typical" Trauma population.
Key exclusion criteria (6 listed)
- All patients admitted under "Doe" Status
- All patients with acute cervical spine injuries or facial fractures that oral care will create further harm to the patient (physician order stating "no oral care to be given" will be in chart)
- All patients with Oral Trauma or Oral Surgery
- All minors (Study will be completed in Adult Critical Care Units)
- Patients with allergy to chlorhexidine
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 |
|---|---|---|
| Chlorhexidine gluconateAlso: Peridex0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa. | Drug | Chlorhexidine Oral Care Regimen |
| ToothpasteBrushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste. | Other | Standard Oral Care Regimen |
Primary outcome
Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients
Time frame: 18 Months
Examination of number of participants who do not develop oral bacteria and Ventilator Associated Pneumonia when an oral rinse containing 0.12% Chlorhexidine Gluconate is used as part of a oral care protocol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ventilator Associated Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
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.
Tracy Thomas, MSN principal investigator
St. Joseph's Hospital and Medical Center, Phoenix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine gluconate and Toothpaste in people with Ventilator Associated Pneumonia, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
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 6 Feb 2017. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients (time frame: 18 Months). 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 6 Feb 2017.