Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 3M | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate | Drug | 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 Months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tracy Thomas, MSN | St. Joseph's Hospital and Medical Center, Phoenix | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States |
Patients were randomized into groups after enrollment.
Patients were recruited upon arrival to the Intensive Care Unit, or after mechanical ventilation was initiated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Oral Care Regimen | Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste. |
| FG001 | Chlorhexidine Oral Care Regimen | Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Oral Care Regimen | Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste. |
| BG001 | Chlorhexidine Oral Care Regimen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to Treat Analysis Used | Posted | Number | participants | 18 Months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Oral Care Regimen | Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste. |
Not provided
Not provided
Enrolling of trauma patients - consenting patients with unknown identification or next of kin status led to small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy L. Thomas MSN RN CCRN ACNS-BC | SJHMC | 602-406-2567 | Tracy.Thomas007@dignityhealth.org |
Not provided
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
Not provided
Not provided
| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Toothpaste | Other | Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste. |
|
Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Chlorhexidine Oral Care Regimen | Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa. | 0 | 33 | 0 | 33 |
Not provided
Not provided
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |