Ventilator Associated Pneumonia
Conditions
Keywords
Trauma, Mechanical Ventilation, Ventilator Associated Pneumonia, Oral Care
Brief 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.
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.
Interventions
DRUGChlorhexidine gluconate
0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
OTHERToothpaste
Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
Sponsors
3M
St. Joseph's Hospital and Medical Center, Phoenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited upon arrival to the Intensive Care Unit, or after mechanical ventilation was initiated.
Pre-assignment details
Patients were randomized into groups after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Standard Oral Care Regimen Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste. | 33 |
| Chlorhexidine Oral Care Regimen Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa. | 33 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Removal from Mechanical Ventilation | 3 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Chlorhexidine Oral Care Regimen | Standard Oral Care Regimen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 1 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 32 Participants | 57 Participants |
| Age, Continuous | 45.5 years STANDARD_DEVIATION 19.96 | 41.5 years STANDARD_DEVIATION 16.279 | 43.88 years STANDARD_DEVIATION 18.355 |
| Gender Female | 8 Participants | 11 Participants | 19 Participants |
| Gender Male | 25 Participants | 22 Participants | 47 Participants |
| Region of Enrollment United States | 33 participants | 33 participants | 66 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
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.
Time frame: 18 Months
Population: Intention to Treat Analysis Used
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Oral Care Regimen | Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients | 30 participants |
| Chlorhexidine Oral Care Regimen | Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients | 29 participants |