Table of Contents Introduction…………………….………………………………………………………………….3 Review of literature………... …………………………………………………………………….3 Framework...............................................................................................................................…... 6
Hypothesis…….. …….……….………………………………………………………………….. 6
Research questions……. …….……………………………………………………………….…...6 Methods…………………….…………………………………………………………………..…4 Design …………………………………..………………………………………………….7 Intervention ……………..……………………………..………………………………….. 7 Sample/Setting …………………….…………………………..……………………………7 Power analysis …………………………………..…………….……………………………8 Instrumentation ...............................................................................................................…...8 Data collection ……………………………………..………….……………………………8 Statistics and data analysis …………………………………………………………….…...9
Expected results …………………………………………………………………………………..9
References cited………………………………………………………………………………….10
Appendix A………………………………………………………………………………………13
Appendix B………………………………………………………………………………………14
Appendix C………………………………………………………………………………………15
Appendix D………………………………………………………………………………………16

Ventilator associated pneumonia and chlorhexidine use in the traumatic brain injured patient Ventilator associated pneumonia (VAP), is defined as, a nosocomial pneumonia that develops more than 48 hours following endotrachial intubation and mechanical ventilation, and is a common and serious intensive care unit (ICU) complication. VAP causes noteworthy morbidity, mortality, amplified hospital costs, and increased utilization of healthcare resources, prolonged time for ventilator support, as well as lengthened ICU and hospital stay (Caruso, 2009). Antibiotics (ATBs) have traditionally been used to treat VAP, but the occurrence of resistance remains of concern (Derde & Bonten, 2009). Therefore, the use of a chlorhexidine (CHX) solution, used during oral cleansing, performed by nursing staff, appears to be an attractive and safe alternative for ICU patients. The effectiveness of 0.12% CHX for reducing VAP incidence in elective cardiac surgery patients is well documented (American Association of Critical Care Nurses (AACN), 2007). However, when CHX was tested in a more varied/mixed ICU population, no difference was observed in VAP rates, mortality or length of hospital stay (AACN, 2007). According to Panchabhai et al. (2009), CHX at concentrations less that 0.2% has consistently been shown to have no benefit in trauma ICU patients and suggests that further studies using oral 0.2% CHX solution, in this population, be conducted. The purpose of this study is to examine the effects of 0.2% oral CHX solution, using two different dosing schedules, on the development of VAP, within a 96 hour time frame, starting from admission to ICU, in critically ill mechanically ventilated intubated (MVI) traumatic brain injured (TBI) ICU patients.
Review of literature Ventilator-associated pneumonia (VAP) is the most common infectious complication of the patient population admitted to the intensive care units (ICUs). VAP accounts for prolonged mechanical ventilation, extended length of stay, increased hospital cost and increased mortality rates in the critically ill population. While there are many risk factors for ventilator-associated pneumonia (VAP), one that requires further examination is the colonization of the oropharynx by potential pathogens (Munro, Grap, Jones, McClish & Sessler, 2009; Garcia et al., 2009; Panchabhai, Dangayach, Krishnan, Kothare, Karnad, 2009; Chlebicki & Safdar, 2007; Sona et al., 2009; Mori et al., 2006). Contamination of the oral cavity by pathogenic bacteria is associated with VAP, therefore interventions to reduce bacteria in the oral cavity merits investigation (Munro, Grap, Jones, McClish & Sessler, 2009; Garcia et al., 2009; Panchabhai et al., 2009; Chlebicki & Safdar, 2007; Sona et al., 2009; Mori et al., 2006). The Center for Disease Control and Prevention (CDC) recommends oral hygiene with Chlorhexidine (CHX) in patients in the perioperative period of cardiac surgery but no recommendations regarding medical-surgical ICU patients (Munro et al., 2009; Panchabhai et al., 2009). Chlorhexidine, applied topically, is a broad-spectrum antibacterial agent that has minimal side effects, making it an attractive alternative to antibiotic use if effective. The reviewed literature provides several studies that utilized CHX as a preventive intervention for decreasing VAP incidence with conflicting and confusing results. In some published cases, studies suggest that topical CHX prevents VAP, while other studies suggest CHX had no significant effect on the reduction of VAP incidence. For instance, a randomized controlled study by Munro et al. (2009) contributed a reduction in VAP incidence in med-surg/trauma and neuroscience intensive care units (ICU) to CHX oral cleansing. Also, Koeman et al., (2006) randomized patients to a control group, a group using either oral topical application of 2% CHX or 2% CHX with colistin; both groups had reduced risk of VAP compared with control group. On the other hand, according to Chlebicki & Safdar (2007), a large recent trial by Fourrier et al. failed to find a benefit of CHX for prevention of VAP. Panchabhai et al. (2009) noted that of five previous placebo-controlled studies of ICU patients and CHX use, with various concentrations, only one study showed a statistically significant benefit. Another area of confusion in using CHX to prevent VAP seems to be in the dosing regimen. The aim of the Scannapieco et al. (2009) study was to determine the minimum frequency of CHX to prevent VAP in trauma ICU patients. The study contained a control group and two intervention groups receiving CHX 0.12% either once or twice daily. They concluded that there was a trend for fewer cases of VAP in both CHX groups, but the sample size was not sufficiently large to show a statistically significant reduction in VAP incidence. Some other factors that may have contributed to the confusing, conflicting results of the various studies were the fact that dosing regimens were not always carefully described and concentrations and dosing frequencies varied. Patient populations also varied widely; there were mixed ICU populations, surgical/trauma ICU populations and populations undergoing cardiac surgery. Furthermore, the medium in which CHX was administered differed. Nasal applications were used, typically with cardiac surgery patients, as well as oral topical CHX solutions and CHX gel. In addition, the study by Koeman et al., (2006) used CHX with the oral antibiotic colistin. Furthermore, even the diagnosis of VAP was determined by various methods. Some of the methods used to determine VAP were the CPIS scale, broncoscopic bronchial lavage (BAL), chest radiograph (CXR), as well as blood and sputum cultures and any combination of the before mentioned. The studies published previously lack specificity and were too general which may account for their conflicting results. Ventilatory support for patients with traumatic brain injury tends to be longer than medically intubated patients and VAP in the traumatic brain injured (TBI) patient can further increase the stay (Fields, 2008). A search of the literature produced limited studies using chlorhexidine to prevent or decrease the incidence of VAP in the TBI patient. Therefore, this study compares the relationship between two different dosing regimens using CHX and the effect on the incidence of VAP, length of stay and oral decontamination. Results will provide clinicians with meaningful data to aid in the selection of cost effective measures to prevent VAP in the TBI population.
Framework
Orlando’s five conceptual theory concepts and modern day five nursing processes are interconnected. It is through this framework that the research proposal of decreasing ventilator-associated pneumonia (VAP) incidences in traumatic brain injured (TBI) mechanically ventilated intubated, intensive care unit (MVI-ICU) patients is used. Refer to figure C1 and D2 respectively.
Hypothesis
It is hypothesized that 0.2% CHX solution will decrease the VAP development in TBI, MVI-ICU patients using an every 4 hour frequency compared to an every 2 hour dosing regimen.
Research questions 1. What is the relationship between TBI patients receiving oral topical application of 0.2% CHX solution every 4 hour in comparison to every 2-hour dosing regimen on VAP incidence? 2. What is the relationship between TBI patients receiving oral topical application of 0.2% CHX solution every 4 hour in comparison to every 2 hour dosing regimen on the length of ventilator days and length of ICU stay? 3. What is the relationship between TBI patients receiving) 0.2% solution every 4 hour in comparison to every 2 hour dosing regimen on pathogenic bacteria colonization in the oral cavity?
Methods
Design A quasi-experimental, pretest and posttest design with two comparison treatments and historical controls were used as a comparison group for this study. A convenience sample with random assignment was used. This study was approved by an Institutional review board (IRB) of a major northeastern hospital in the United States.
Intervention
Patients were randomly assigned to 1 of 2 treatment groups. A 0.2% solution of CHX (5ml) was applied using a saturated oral foam applicator twice daily (at 10am and 10pm) for treatment group I and four times daily (at 10am, 4pm, 10pm and 4am) for treatment group II (Panchabhai et al., 2009). Applications were for one minute, all teeth, buccal mucosa, gingival, floor of the mouth and tongue were swabbed. A yankauer suction catheter was used as needed to suction excess saliva and water from the mouth as the intervention was performed. A commercially available 0.2% CHX solution was dispensed by the investigational pharmacy for use in the study. All patients were examined daily for the presence of VAP by clinical pulmonary infection score (CPIS) scores. Sputum cultures were collected on days 2 and 4 unless extubated prior to the end of the study. Staff nurses of the 2 ICU’s were instructed on the procedure to be used to perform oral care with CHX. They were given laminated cards with basic instructions after viewing a PowerPoint presentation designed to increase understanding of the study and its objectives, as well as the CHX oral care procedure to be followed during the study. All procedures previously implemented to reduce VAP, excluding previous CHX use, were maintained during the study.
Sample/Setting
Subjects were assembled from 2 Intensive Care Units (ICUs) at a level 1 trauma and teaching hospital, found in the urban area of Cleveland, Ohio. Subjects were adults, 18 years of age and older, admitted in the surgical/trauma/neuroscience ICUs. They were randomly selected, and screened for inclusions and exclusions similar to that of previous studies for consistency in findings (Table A1). The length of participation the subjects remained in the study was 96 hours except if extubated or death occurred during the study. The day of extubation was the day that the subject’s participation in the study ended.
Power analysis Based on previous studies, it was estimated that 50 participants per treatment group had to be recruited in order to provide 80% power, with an alpha error of .05 for detecting the frequency of VAP between the two groups (Kostadima, Kaditis, Alexopoulos, Zskynthinos, & Sfyras, 2005).
Instrumentation
Clinical criteria used in determining (VAP) for the purposes of this study include the clinical pulmonary infection score (CPIS). CPIS is a diagnostic algorithm that relies on six clinical indicators to diagnose VAP (Table B2) (Camargo & Fernando et al., 2004; Luyt, Chastre & Fagon, 2004).
Data collection Demographic information was recorded at the time of admission to the ICU and included age, sex and diagnosis. A designated research nurse conducted surveillance of VAP. Surveillance information was recorded on a computer database and included intubation date; extubation date; date of admission, transfer or death; CPIS results. Determination of days on mechanical ventilation was based on information provided by respiratory therapy. Blood tests and chest radiographic examination were executed daily and evaluated by designated trauma physicians involved in the study.
Statistics and data analysis The major statistical procedure applied to the study was the t-test. A value of p < 0.05 was considered statistically significant. Frequency of VAP incidence was the primary outcome measure. Secondary outcome measures were length of ventilator days and length of ICU days.
Expected Results The incidence of VAP in the 4 times daily CHX use is expected to be lower than in the twice-daily group. It is through the results of this study that optimal frequency of CHX use will be determined. It is expected that 4 times daily CHX use will reduce the length of ventilator days and ICU days.

References
American Association of Critical Care Nurses. (2007, October). Oral Care in the Critically Ill (AACN Practice Alert).
Camargo, A., Fernando, L., De Marco, F., Barbas, C., Hoelz, C., Bueno, M., Rodrigues, M., Amado, V., Caserta, R., Martino, M., Pasternak, J., Knobel, E. (2004). Ventilator associated pneumonia: comparison between quantitative and qualitative cultures of tracheal aspirates. Critical Care, 8:R422-R430 doi:10.1186/cc2965.
Chlelbicki, M.P., & Safdar, N. (2007). Topical chlorhexidine for prevention of ventilator-associated pneumonia: A meta analysis. Critical Care Med, 35, 595-602. Doi: 10.1097/01.ccm.000253395.70708.ac
Derde, L.P., & Bonten, M.J. (2009). Oropharyngeal decontamination in intensive care patients: less is not more. Critical Care, 13 183 doi:10.118d6/cc8013.
Fields, L.B. (2008). Oral care intervention to reduce incidence of ventilator-associated pniumonia in the neurologic intensive care unit. American Association of Neuroscience Nurses, 40, 291-298.
Garcia, R., Jendresky, L., Colbert, L., Bailey, A., Zaman, M., & Majumder, M. (2009). Reducing ventilator-associated pneumonia through advanced oral-dental care: A 48-month study. American Association of Critical Care, 18, 523-532.
Kastadima, E., Kaditis, A.G., Alexopoulos, E.I., Zskynthinos E. & Sfyras, D. (2005). Early gastrostomy reduces the rate of ventilator-associated pneumonia in stroke or head injury patients. European Respiratory Journal, 26, 106-111. Doi: 10.1183/09031936.05.00096104.

Koeman, M., Van der Ven, A.J.A.M., Hak, E., Joore, H.C.A., Kaasjager, K., G.A. de Smet, A., Ramsey, G., Dormans, T.P.J., …Bonten, M.J.M. (2006). Oral decontamination with chlorhexidine reduces the incidence of ventilator-associated pneumonia. Respiratory and Critical Care Medicine, 173, 1348-1355. Doi: 10.1164/rccm.200505-820OC.
Luyte, C.E., Chastre, J. & Fagon, J.V. (2004). Value of the clinical pulmonary infection score for the identification and management of ventilator-associated pneumonia. Intensive Care Medicine, 30, 844-852. doi:10.1007/s00134-003-2125-0.
Mori, H., Hirasawa, H., Oda, S., Shiga, H., Matsuda, K., & Nakamura, M. (2006). Oral care reduces incidence of ventilator-associated pneumonia in ICU populations. Intensive Care Med, 134, 230-236. Doi:10.1007/s00134-005-0014-4.
Munro, C.L., Grap, M.J., Jones, D.J., McClish, D.K., & Sessler, C.N. (2009). Chlorhexidine, toothbrushing, and preventing ventilator –associatedpneumonia in critically ill adults. American Association of Critical Care, 18, 428-437. Doi: 10.4037/ajcc2009792.
Panchabhai, T.S., & Dangayach, N.D. (2009). Role of chlorhexidine gluconate in ventilator-associated pneumonia prevention strategies in ICU patients: where are we headed? Critical Care, doi:10.1186/cc8165.
Panchabhai, T.S., Dangayach, N.S., Krishnan, A., Kothari, V.M., & Kamad, D.R., (2009). Oropharyngeal cleansing with 0.2% chlorhexidine for prevention of nosocomial pneumonia in critically ill patients: An open-label randomized trail with 0.01% potassium permanganate as control. Chest, 135, 1150-1156. Doi: 10.1378/chest.08-1321.
Scannapieco, F.A., Jihnhee, Y., Krishnan, R., Vacanti, A., Owens, S.I., Wood, K. & Mylotte, J.M. (2009). A randomized trial of chlorhexidine gluconate on oral bacterial pathogens in mechanically ventilated patients. Critical Care, 13 (4), R117.
Schmeiding, N.J. (1986). Orlando’s Theory. In P. Winstead-Fry (Ed.), Case studies in nursing theory. (pp. 1-36). New York: National League for Nursing.
Sona, C.S., Zack, J.E., Schallom, M.E., McSweeney, M., McMullen, K., & Thomas, J., et al. (2009). The impact of a simple, low-cost oral care protocol on ventilator-associated pniumaonia rates in a surgical intensive care unit. Journal of Intensive Care Medicine, 24, 54-62. Doi:10.1177/0885066608326972.

Appendix A
Table 1
Inclusion and Exclusion Criteria Inclusions | Exclusions | At least 18 years old | Not intubated within 24 hours of admission | Admitted to ICU | Previously intubated during present hospital stay | Diagnosed with TBI | Pregnancy | Intubated and mechanically ventilated within 24 hours of admission | Oral or lung cancer | | Pre-existing pneumonia | | Allergy to CHX | | Edentulous subjects |

Appendix B
Table 2
The modified Clinical Pulmonary Infection Score (Carmago & Fernando et al., 2004) CPIS Points | 0 | 1 | 2 | Tracheal secretions | Rare | Abundant | Abundant + Purulent | Chest X-ray infiltrates | No infiltrate | Diffused | Localized | Temperature, C | >36.5 and >38.4 | >38.5 and <38.9 | >39.0 or <36.0 | Leukocytes count, per mm3 | >4,000 and <11,000 | <4,000 or >11,000 | <4,000 or >11,000 +band forms >500 | PAo2/FIo2, mm Hg | >240 or ARDS | | <240 and no evidence of ARDS | Microbiology | Negative | | Positive |

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Appendix C

Figure 1. Orlando’s theory and the nursing process. Schmeiding, N.J. (1986). Orlando’s Theory. In P. Winstead-Fry (Ed.), Case studies in nursing theory. (pp. 1-36). New York: National League for Nursing.

Appendix D

Figure 2. Orlando’s theory and VAP/CHX study. Schmeiding, N.J. (1986). Orlando’s Theory. In P. Winstead-Fry (Ed.), Case studies in nursing theory. (pp. 1-36). New York: National League for Nursing.