Oral Hygiene Methodology There is a significant amount of research that shows statistical correlation between oropharyngeal bacterial colonization and the presence bacteria responsible for ventilator associated pneumonia (VAP). Several interventions have been shown as effective in reducing the incidence of VAP, but many have not gained widespread clinical use in a majority of hospitals. Research does show that the amount of oropharyngeal bacteria present in the mouth and oral cavity has a relationship to the propensity of developing VAP. This is likely due to the lack of appropriate levels of oral hygiene combined with the bacterial colonization of ventilator equipment. We expect that oral and mouth washes regularly administrated that include chlorohexedine will kill bacteria and reduce incidence of VAP infections on ICU patients. The aim of this study will be to survey the efficacy of chlorohexdedine mouth washes in a randomized group of patients who were placed in an ICU ward at X Hospital between (dates).

Support for Methodology -- If VAP is allowed to spread, serious measures are often needed. The issue for most researchers is the cross-contamination with invasive devices in lieu of appropriate use of antibiotics or other substances that prevent the bacteria responsible for VAP (Linvingtston, 2000). Extensive literature reviews showed that physical, positional, and pharmacological interventions may indeed affect the rates and contamination levels of VAP causing bacteria, which also show to place certain patients at a higher risk for gastrointestinal bleeding (Dodek, P., et al., 2004). While it appears that aspiration of gastric secretions contributes to VAP, it also appears that continuous oscillation or at least regularly turning of patients does help decrease the issue which, depending on the cost effectiveness of labor, may be more expensive that adding oral mouthwashes (Collard & Saint, 2005).

Topical use of chlorhexidine resulted in a reduced incidence of VAP in several trials, but had different levels of efficacy depending on the reason for the patient's stay in ICU, with the most benefit going to cardiac surgery patients (Chlebicki & Safdar, 2007). Additional randomized studies showed that patients who received oral decontamination with 2% chlorhexidine or normal saline solution four times per day showed that there was really no significant different in rates of VAP. The saline group did have a small number of increased incidents (12 out of 105 as opposed to 5 out of 102, but saline appears to also be effective in reducing VAP (Tantipong, H., et al., 2008). Still, there are a number of research studies that validate the protocol we will be using to test levels of chlorhexidine on patients using simply one set of variable with solution, one set not (Sharma & Kaur, 2012; Sebastian, M., et al., 2012).

Research Design - A quasi-experimental design will be used to compare two groups of patients, all admitted to an ICU ward and. The study will involve a group in which 11 ICU patients who were fitted with a ventilator were studied and 11 patients not on ventilators. Patients are between 17-72 years old, and exclusion criteria will be patients under 18, those who already have infection pneumonia, and/or patients who have been transferred from another medical facility.

Protection of Patient's Rights - Each patient will be asked to agree to the study, and will be randomly numbered -- V1, V2; R1, R2, etc. Only pertinent demographic information will be collected from the patients, and no personal identification data will be collected or saved. Pre- and post-observational studies included mechanically ventilated patients. Rates of VAP were calculated and analysis done. Only bacterial counts and tests to determine VAP were part of this study; other issues surrounding ventilation and/or other bodily infections based on ICU care were ignored. Permission to conduct the study will be obtained from X University and the Institutional Review Board. In addition, the study will be approved by the hospital's research and ethics committee, as well as the Director of ICU at Y Hospital. An informed consent form will be signed by each patient and/or family member within the study (See Appendix A).

Experimental Methodology- A prospective study will be performed with 22 patients in a trauma ward, 11 on a ventilator, and 11 not on a ventilator. The protocol will be such that each patient will be given a 6oz. cup of a chlorhexidine oral cleansing three times daily, once after breakfast or before 9am; once between 1-2pm, and once between 7pm-8pm. Each patient will be asked to swish the solution for a minimum of 30 seconds if able; if not, medical personnel will artificially use a syringe to spray the mouth, tongue and inner lip area with the solution and allow it to drain into a cloth or pan. Swabs will be taken just prior to the use of the mouthwash. A solution of 2% Chlorhexidine will be used in the rinse. The solution will be alcohol based, but as low a dose as possible to ensure that the chlorhexidine dissolves properly.

For the purposes of this study, the swab results will be limited...

Additional data with absolute amounts may be given at an additional time based on the study protocol, timeframe, and data.
Definitions for Bacterial Count: L = 10% or 31%

Definitions for BC = L=4.3-5.1; M= 5.2-6.9; H=7.0=8.7; XH= >8.8

Data Collection -- The study will consist of 15 days' worth of measurements. Every other day, each patient will receive a daily culture swab that will be sent to the lab for bacterial grow out. On days 1, 5, 10, and 15, blood will be drawn for a CBC white count rate; the results will be recorded on an individual data control form:

Patient: A1

Start Date:

End Date:

V or N

Day 1 -- CBC

Day 5- CBC

Day 10 -- CBC

Day 15- CBC

Day 1- Swab Results

Day 3- Swab Results

Day 5- Swab Results

Day 7- Swab Results

Day 9- Swab Results

Day 11- Swab Results

Day 13- Swab Results

Day 15- Swab Results

In addition, each patient will be given a chest-x-ray on Day 11 of the study, specifically looking for anomalies.

Protocol/Time Frame -- Swabs will be taken by authorized member of nursing staff using a sterilized swab post that has been prelabeled. The top of the swab will be encased on plastic, and once all data is collected, will be sent to the lab for culture. Sterile measures will be used by all personnel (gloves, masks, etc.). On Days 1, 10, and 15 (4 times), blood will be drawn for CBC test.

Samples were sent to AAA Lab for culture and results. Bacterial culture grow out protocol was limited in this case, to oropharyngeal bacteria of a type to be determined by the study.

Analysis Plan -- Data will be collected at the end of the study and cross-tabulated for further analysis. Because of the small sample size, we are limited in the amount of statistical work we can do with this topic. However, the data will be compared with similar research trials in a longitudinal literature study (for instance, see: Lansford, et al., 2007).

Data -- Upon completion of the study, a chart will be produced which will give the incidences of treatment (See Appendix B). Definitions for Bacterial Count: L = 10% or 31% Definitions for BC = L=4.3-5.1; M= 5.2-6.9; H=7.0=8.7; XH= >8.8

Appendix A -- Informed Consent Form

Research Consent Form

Protocol Director:

Submitted by:

Protocol Title:

Approved/Rejected/Date

Please check one of the following:

____ You are an adult participant in this study.

____ You have the power of attorney or legal right to allow this adult patient to participate in this study:

Legal Name of Individual:

For Questions about this Study: Contact Joe Smith at [HIDDEN] or Description: You are invited to participate in a research study that will attempt to gauge whether use of an oral mouthwash will reduce the incidence of pneumonia in ventilated patients.

Risks and Benefits: There are no anticipated risks with the exception of a potential allergic reaction to the mouthwash, which will be tested prior to the study.

Time: The study will take less than 10 minutes of your time daily; with most of that time being spent by the nurse taking a small throat swab and/or blood draw.

Payments: No payments are implied.

Participant Rights: If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled. The results of this research study may be presented at scientific or professional meetings or published in scientific journals. However, your identity will not be disclosed.

Note: Here are some additional forms for you to use, as you can see, I am running out of pages: http://www.who.int/rpc/research_ethics/informed_consent/en / https://eirb.research.usf.edu/Prod/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5BEC93D33F0BFE684E9BABF4F231A0A81F%5D%5D

Appendix B

Patient

D1S

D3S

D5S

D7S

D9S

D11S

D13S

D15S

D1

XH

4L

2M

3H

2 XH

11L

6L

5M

6L

3M

1H

4L

5M

1H

REFERENCES

Chlebicki, P., & Safdar, N. (2007). Topical chlorhexidine for prevention of ventilator-associated peneumonia: A Meta-analysis. Critical Care Medicine, 35(2), 595-602.

Collard, H., & Saint, S. (2005,…