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Abstract

Aspiration pneumonia is a severe complication affecting patients receiving mechanical ventilation. Studies have shown an increased morbidity rate resulting from aspiration pneumonia in individuals with poor oral hygiene. The purpose of this study was to assess the relationship between oral hygiene and aspiration pneumonia in elderly population. For this study a quasi experimental design was utilized to include a control and experimental group. The convenience sample was comprised of 100 mechanically ventilated elderly patients in a critical care unit who were admitted within 24 hours of intubation. The subjects were assigned to one of two study groups, the control group or the experimental group. The control group received only the standard oral care practices and experimental group received twice daily brushing with 0.12% chlorhexidine in addition to the standard oral care practices. The proposal of this study is that the application of an oral hygiene regimen that includes 0.12% chlorhexidine gluconate will reduce the incidence of aspiration pneumonia and will decrease the rate of mortality from aspiration pneumonia better than standard oral hygiene practices. Keywords: elderly, aspiration pneumonia, mechanically ventilated, oral hygiene

Introduction

Aspiration pneumonia (AP) is an alveolar space infection resulting from the inhalation of pathogenic material from the oropharynx (Tintinalli, 2010). This disease, which mostly affects older adults, has been increasingly recognized as an important health problem. Population at risk of AP includes persons over 65 years old because of elevated incidence of dysphagia and gastrointestinal reflux, and in critically ill patients in intensive care receiving mechanical ventilation. Patients with periodontal disease and poor oral hygiene have higher potential to develop bacterial colonization in lungs. Species frequently found in AP are Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Enterobacteriaceae, Pseudomonas aeruginosa and gram-negative organisms(Tintinalli, 2010).

Ventilator-associated pneumonia (VAP) is defined as pneumonia in a patient receiving mechanical ventilation that was neither present nor developing at the time of intubation (Muro, Grap, Elswick, McKinney, Sessler & Hummel, 2006). Mortality rates are two to three times higher in patients with VAP than in patients without VAP (Garcia, Jendresky, Colbert, Bailey, Zaman, & Majumder, 2009). Poor oral hygiene is an important risk factor for the development of VAP and is associated with an increased mortality rate. One of the most serious complications of intubated critically ill patients is aspiration and subsequent pneumonia development. Healthcare associated pneumonia is an infection in the lungs commonly perceived to be caused by food or liquid that is inhaled through the trachea into the lungs, rather than into the stomach (Cuttler & David, 2005). Investigations have suggested that adequate oral care is needed to reduce AP and death from AP but the exact formula has eluded researchers to this day.

Exact definitions of good oral hygiene, poor oral hygiene and inadequate oral hygiene are usually different among studies. In addition, the tools used in these studies that gauge overall oral hygiene are not universal (Abe, Ishihara, Adachi, & Okuda, 2006; Adachi, Ishihara, Abe, & Okuda, 2007; Quagliarello, Ginter, Han, Ness, Allore, & Tinetti, 2005). Further research is needed into the precise regimen that yields the greatest quality of oral hygiene while maintaining cost containments efforts.Oral comfort and hygiene measures have long been an important aspect of nursing care for patients receiving mechanical ventilation. There is also a strong correlation between oral hygiene and acquired pneumonia, but there is a gap that exists between the oral care measures that are indicated and the actual care that patients receive (Cuttler & David, 2005). This gap makes the comparison between studies more difficult and may impede the development of a comprehensive oral care plan (Abe et al., 2006; Adachi et al., 2007; Quagliarello et al., 2005).

Research Problem

Studies have found that good oral hygiene was associated with reduced numbers of pneumonia and deaths from pneumonia, but definitions of adequate oral care and good oral care have not been uniform comparisons. Reducing the rates of pneumonia and pneumonia related deaths in the elderly population may be accomplished through the development of a universal protocol for oral hygiene.

Purpose of the Study

The purpose of this study is to assess the relationship between oral hygiene and aspiration pneumonia in elderly, mechanically ventilated patients in a critical care unit.

Specific Aims

Aims

The objective of this study is to determine the effect of implementing standard oral care practices with the addition of twice daily application of 0.12% chlorhexadine on the rate of aspiration pneumonia and mortality in the elderly population. The use of 0.12% chlorhexadine as part of an oral hygiene protocol is not standard practice in many hospital settings. Information obtained through research could encourage the implementation of this oral hygiene practice because it would be evidence based. Since evidence based practice has become the foundation of the nursing profession today, this oral hygiene practice could become the standard.

Research Question

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What is the relationship between oral hygiene and aspiration pneumonia in the elderly population?

Definition of Terms

Intubation: The insertion of a tube via the mouth or nares into the larynx. The purpose of intubation in this study was to provide a patent airway and the administration of oxygen.

Nosocomial Pneumonia: An inflammation of the lung with consolidation and exudation that is pertaining to or originating in the hospital (Bopp, Darby, Loftin, & Broscious, 2006).

Ventilator Associated Pneumonia: The development of pneumonia as a result of the presence of an endotracheal tube.

Mechanical Ventilation: The insertion of an endotracheal tube that is attached to a ventilator in order to assist the patient in breathing.

Dysphasia: An impairment of swallowing ability.

Elderly Population: Persons age 65 years or greater for purposes of this study.

Leukocytosis: An increase in the total number of white blood cells.

Mucositis: The painful inflammation and ulceration of the mucous membranes lining the digestive tract.

Hypotheses

The use of an oral hygiene regimen, which includes.12% chlorhexidine gluconate, in the experimental group will produce a decrease in the incidence of aspiration pneumonia and a decrease in mortality from pneumonia compared to the control group who will receive standard oral care.

Significance of the Problem

Literature Review

One of the most serious complications in the critically ill patients is aspiration resulting in healthcare associated pneumonia which is an infection in the lungs commonly perceived to be caused by food or liquid that goes down the trachea into the lungs, rather than into the stomach (Cuttler & David, 2005).Ventilator-associated pneumonia (VAP) is a complication associated with the delivery of care in the acute care setting that nurses can help minimize. In the critical care setting, nurses provide oral hygiene to ventilated patients. Therefore, nurses have the obligation and responsibility to ensure that proper oral hygiene practices are effectively performed on a routine schedule. Currently, nosocomial infections related to acquired pneumonia in ventilated patients is the second most common nosocomial infection in the United States. The prevalence of nosocomial pneumonia greatly increases morbidity and mortality and increases the length of stay in the critical care unit which leads to an increase in the overall cost (Darby, Loftin, & Broscious, 2006).

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Nosocomial Infections related to Intubated Patients

There is a particular risk for hospital-acquired pneumonia among patients in the critical care units (CCU) undergoing intubation for airway management because these patients are predisposed to develop colonies of more virulent pathogens than found in the normal oral environment of healthy people (Darby, Loftin & Broscious, 2006). According to Cutler and David (2005), unlike healthy adults, hospitalized and institutionalized patients are at great risk for direct introduction or micro-aspiration of pathogens into the lower part of the respiratory tract when respiratory deterioration necessitates intubation. Therefore, reducing the patient’s risk through diligent oral care interventions has become critical in preventing adverse outcomes such as ventilated-associated pneumonia (VAP).

Studies have looked at numerous interventions to reduce the level of oropharyngeal and gastrointestinal microorganisms that could potentially be aspirated into the lungs. One the proposed methods utilized topical and systemic antibiotics termed selective decontamination of the digestive tract (SDD). This pilot study found that the use of topical antimicrobials, such as 0.12% chlorhexidine gluconate, for oral decontamination for intubated patients was effective. This method involved the administration of antibiotic paste or solutions into the oropharynx or trachea of patients receiving mechanical ventilation (Garcia, Jendresky, Colbert, Bailey, Zaman, & Majumder, 2009).

Chlorhexidine gluconate mouth rinse has been used successfully for many years in healthy patients to control dental plaque and gingival inflammation as well as showing benefits in reducing oral infections and severe mucositis during cancer therapy. Eligible patients were identified through screening in the CCU during this pilot study. While participating in the study, the subjects received twice daily oral hygiene care that included: brushing the cheeks, teeth and endotracheal tube with a suctioning toothbrush. Both the experiment and control group received the standard oral care six times per day utilizing a soft foam swab and half strength hydrogen peroxide. All the oral care was performed by the nursing staff and those patients that developed nosocomial pneumonia were monitored until hospital discharge.

Munro, Grap, Elswick, McKinney, Sessler, & Hummel (2006) used a specific study to describe the relationship between oral health status and the development of VAP. They specifically examined the relationship between oral health status and the development of VAP by performing a thorough assessment of the oral cavity, cultures or oral specimens, salivary volume, and salivary immune components. The Clinical Pulmonary Infection Score (CPIS) was the tool utilized for the development of criteria for examining this relationship. The CPIS tool assigns points to six variables:

Points for each variable of the CPIS were assumed, yielding a total CPIS (range 0-12), which provided a range of scores for data analysis. VAP was defined as occurring when the patient had a chest radiograph showing new or progressive infiltrate, consolidation, cavitations, or pleural effusion in conjunction with either new onset of purulent sputum or change in character of sputum, an organism isolated from blood, or the isolation of an etiologic agent from a specimen obtained via suction aspiration through the endotracheal or tracheostomy tube (Garcia, Jendresky, Colbert, Bailey, Zaman, & Majumder, 2009). The Institute for Healthcare Improvement indicated fourteen hospitals have achieved a zero infection rate in their report of outcomes stemming from a national initiative on VAP prevention. Of these, at least eight institutions had added advance oral and dental care tools as an integral part of the bundle components.

Few studies have addressed comprehensive or individual oral care practices for preventing VAP in patients receiving mechanical ventilation. Despite numerous guidelines designed to prevent VAP, empirical evidence supporting the various aspects of the protocols is limited (Feider, Mitchell, & Bridges, 2010). Oral comfort and hygiene measures have long been an important aspect of nursing care for patients receiving mechanical ventilation. There is a strong correlation between the oral care is actually being performed and acquired pneumonia (Cuttler and David, 2005). The study of the relationship between VAP and oral health status helps to emphasize the importance and impact that comprehensive oral hygiene has on reducing or preventing the development of mechanical ventilation acquired pneumonia.

Limitations of the Studies

Limitations of the studies are their applicability to standard nursing care. There is a lack of sufficient studies that examine the correlation between mechanical ventilation acquired pneumonia and the amount of oral health care management is being performed by nursing staff. It is apparent that there is limited, if any, accountability for nurses that do not follow oral hygiene protocols and procedures. Further research is needed that captures comprehensive data on oral care frequency and duration that is actually observed and monitored by investigators. An evidence-based standard oral assessment tool for intubated critical care patients is needed in addition to implementing easy to use oral care policies. Follow up measures to assess the effectiveness of the tool and the interventions in decreasing VAP incidence rates should be included in the research studies (Feider, Mitchell & Bridges, 2010).

From the literature review, one can determine that the different tools used to gauge overall oral hygiene are not universal (Abe, Ishihara, Adachi, & Okuda, 2006; Adachi, Ishihara, Abe, & Okuda, 2007; Quagliarello, Ginter, Han, Ness, Allore, & Tinetti, 2005). It was also noted that there is not an exact definition of good or poor oral hygiene among the different studies. Ultimately, nurses have the obligation to review their oral hygiene assessment and practice according to their hospital protocol and ensure that the delivery of care is evidence based. Oral hygiene should be considered as an integral and vital aspect of comfort care and a crucial element in minimizing the development of mechanical acquired ventilation pneumonia.

Methods

Design

A quasi experimental design with a control group and an experimental group was used in this study. This type of research design has an intervention and control group but does not have randomization in selecting the sample (Polit & Beck, 2008). Convenience sampling was used. Random numbers table was utilized in placing the subjects into the experimental and control group. The participants were randomly assigned to an experimental or control group in equal proportion. A descriptive design was utilized to describe the participants’ characteristics.

Sample

The convenience sample consisted of 100 participants. Of the 200 patients who entered the critical care unit and were asked to participate in the study, half declined. This sample size was based on a previous pilot study that had a desired sample size of 30-60 subjects, but failed to achieve this number (Bopp, Darby, Loftin, & Broscious, 2006). Several other studies with similar designs and good data quality had 60 to 190 participants (Adachi, Ishihara, Abe, & Okuda, 2007; Munro, Grap, Elswick, McKinney, Sessler, & Hummel, 2006; Watando et al., 2005). In case of recruitment issues, the number of participants asked to participate was decided to be on the higher end so that there would be at least 60 study subjects. The oral hygiene interventions of standard oral care versus care with chlorhexidine gluconate were performed over a period of twelve months. The endpoint was the documented pneumonia during the intubation period in the experimental and control groups. Study subjects that died from pneumonia were noted in the study.

Patients were enrolled into this study within 24 hours of intubation. Inclusion criteria included: intubation of less than or equal to 24 hours, and age greater than or equal to 65 years old. Exclusion criteria included those patients who were admitted to the hospital for pneumonia and then had to be intubated, history of an allergy to chlorhexidine gluconate, high risk for infective endocarditis and those with a history of COPD or asthma. The participants had a variety of chronic medical conditions including diabetes, dementia, heart disease, kidney disease, previous stroke, high blood pressure, arrhythmias, and inactive stomach ulcers. The sample consisted of 65 women and 35 men. Mean age was 80.

12 % Chlorhexidine Gluconate

.12% chlorhexidine gluconate is an oral rinse used to control dental plaque and gingivitis in healthy and ill patients. Dosing recommendations are twice daily rinsing with 5-10ml of .12% chlorhexidine gluconate. The uses and indications for this drug are during chemotherapeutic regimens in an effort to reduce the acquisition of mucositis and to minimize infections of the mouth. The drug is also used to reduce soft tissue inflammation in those afflicted with AIDS. The rationale behind using .12% chlorhexidine gluconate in this study relies on the evidence that suggests patients in critical care units become colonized with microorganisms in the oral cavity that later contribute to the development of pneumonia through aspiration of these bacteria into the lungs. If the oropharyngeal bacteria are the key factors in the development of aspiration pneumonia, then the use of twice daily .12% chlorohexidine gluconate along with thorough mouth care will likely decrease rates of pneumonia. In turn, costs and mortality will be reduced contributing to the superior health and wellness of the intubated elderly adult population (Bopp, Darby, Loftin, & Broscious, 2006).

Protection of Human Subjects

The study proposal was reviewed and approved by the Florida International University School of Nursing Research Committee and the hospital’s institutional review board. All IRBs’ approved of the conduct of the study. The consent form stated that there were no known risks, but possible benefits involved in participating in the study. The consent form included telephone numbers of the researchers should any study subject/legally authorized health care representative want more information about the study. Informed consent was received from the participants legally authorized medical representatives for participation in the study because many patients admitted to the critical care unit were unable to give full informed consent for themselves as they were under sedation and intubated. In order to attain the highest level of anonymity and confidentiality, subjects’ names were not included on any of the data collection tools. Nurses who were caring for the patients and recording the interventions were asked not to put any patient identifying material on them. Instead all the paper documentation was coded by numbers not name for the protection of each participant.

Setting

Participants for this study were elderly patients admitted to the critical care unit in a 500 bed teaching hospital in South Florida. The critical care unit has 40 beds. This unit receives about 3000 admissions each year with approximately 60% of those being patients requiring mechanical ventilation. The subjects were orally or nasally intubated and receiving mechanical ventilation. The participants were randomly assigned to an experimental or control group in equal proportion. Oral hygiene interventions took place at the bedside by the registered nurse assigned to the patient. The nurses were trained on the oral care protocol prior to initiation of the study. Questions were answered and staff was allowed to opt out from aiding with the study, but all agreed to assist with the study.

Data Collection Procedure

After permission was received from the University School of Nursing Research Committee, the Director of Nursing was approached regarding the research study. Once permission was granted to conduct the study in the hospital’s critical care unit, the study was submitted and reviewed by the hospital’s Internal Review Board (IRB). Upon receiving permission to begin the study from the IRB, data collection was initiated.

Eligibility to participate in the study was determined by the clinical manager. The clinical manager of the critical care unit agreed to be the contact and support person for the bedside nurse’s questions and/or concerns. The staff nurses from both day shift and night shift agreed to assume the role of data collector. After eligible subjects were identified by the clinical manager, the nurse data collectors would introduce themselves; give a statement regarding the nature of the research, and an explanation of the data collection procedures. The patient or their health care representative was then presented with the consent to participate form. The staff nurses acting as data collectors were given both the inclusion and exclusion criteria for this study as well as an explanation of the data collection procedures. Each of the nurse data collectors attended one of several educational sessions conducted by two dental hygiene researchers on the twice daily oral hygiene care protocol with chlorhexidine gluconate to the experimental group or the standard oral care protocol that the hospital already followed to the control group. The nurse data collectors kept a record of the oral hygiene administration and any adverse effects to the subjects within their medical chart. The lead research investigator visited the CCU every two to three days at random times to review record keeping and note any adverse effects.

Intervention

Oral hygiene comprises the care of the teeth, gingiva, hard palate and tongue. The control group would receive standard oral care which includes: oral swabbing, moisturizing and suctioning every two hours and PRN and brushing the teeth, gingiva, hard palate and tongue twice a day with 1.5% hydrogen peroxide solution. The experimental group would receive the oral swabbing, moisturizing and suctioning every two hours and PRN with the addition of twice daily brushings of the teeth, gingiva, hard palate and tongue with 0.12% chlorhexidine gluconate. Temperature of each subject would be measured every four hours. If the subject was febrile for two consecutive measurements, a sputum sample would be collected and sent for culture and organism sensitivity reports. A portable chest x-ray would be performed every AM and interpreted by the radiologist and reviewed by the primary physician and nurse.

Instruments

Patient demographic data were recorded at the time of admission to the critical care unit. This data included sex, age, reason for admission, and Acute Physiology and Chronic Health Evaluation (APACHE) II score. The lead research investigator utilized an intake form to record date of admission, intubation date, temperature, chest radiograph results, leukocytosis, sputum culture results, extubation date, number of ventilator days, length of stay in the critical care unit, and deaths.

An oral cleansing protocol was developed from an existing protocol for the experimental group to include the use of .12% chlorhexidine gluconate. This protocol was presented to the nurse data collectors and verbalization with demonstration of understanding was assessed by the lead researcher. The protocol was placed in the patient’s bedside chart and the respiratory therapy daily documentation clipboard. There were several physical instruments utilized in this study to perform and evaluate the oral hygiene procedures. These tools included an in-line suction catheter, oral care kits, half strength hydrogen peroxide, chlorhexidine gluconate, toothettes, suctioning dental brush, covered yankauer suction, and an applicator swap impregnated with moisturizer. Evaluation instruments included chest radiographs, vital signs monitors, and laboratory equipment.

The Clinical Pulmonary Infection Score (CPIS) is a tool utilized to determine the development of aspiration pneumonia. The CPIS assigns points for easily obtained variables such as: temperature, white blood cell count, tracheal secretions, oxygenation, chest radiograph results, and cultures (Munro, Grap, Elswick, McKinney, Sessler, & Hummel, 2006). The points for each of these variables are totaled and provide a range of scores for data analysis.

The Acute Physiology and Chronic Health Evaluation II (APACHE II) is a scoring system utilized to determine the severity of illness in the critical care unit. The APACHE II scores for this study allowed for a comprehensive representation of the participants demographics. The APACHE II provided a numerical score from 0 to 71 for each of the study participants. The scores are based on several physiological measurements such as blood pressure, heart rate, respiratory rate, temperature rate, Glascow Coma Scale, laboratory values, arterial blood gases, age and history of immunosuppression or organ failure. A higher APACHE II score implies a more severe disease process and the greater the risk of death.

The Student t test and Mann Whitney test were utilized to evaluate the variables. The t test evaluates those variables with a normal distribution. Although there were two distinct groups within the study, several of the variables were equal among the two populations. However, not all of the variables were equally distributed within this study. The irregularity of the time variable made it necessary to utilize the Mann Whitney test.

Data Analysis

The rate of pneumonia in ventilated patients was the primary outcome measure. Mortality and length of stay in the critical care unit were the secondary outcomes. Descriptive statistics were used to summarize the characteristics of the study population. Mean, percentages and standard deviations (SD) were calculated for all of the variables and recorded. Demographic patient data were recorded at the time of admission to the critical care unit and included sex, age, reason for admission, and Acute Physiology and Chronic Health Evaluation (APACHE) II score. A general forward selection multiple regression analysis was used to model the relationship between oral health status and Clinical Pulmonary Infection Score (CPIS). The variables with normal distribution were evaluated using the Student t test and variables with irregular distributions were evaluated using the Mann Whitney. The independent variables of age, level of function, and oral care were evaluated with the Student t test because of the specific population of the subjects. The Mann Whitney test was performed because the length of time that the patients were on mechanical ventilation varied. The APACHE scores and remaining variables were evaluated with the Student t test.

To answer the research question “What is the relationship between oral hygiene and aspiration pneumonia in the elderly?” a commercial statistical analysis package was used to compare the incidence of aspiration pneumonia in patients receiving twice daily oral hygiene with .12% chlorhexadine gluconate and those receiving the standard oral hygiene protocol. Comparisons used in the study were unpaired and 2-tailed; a P level of 0.05 was considered significant in all analyses.

References

Abe, S., Ishihara, K., Adachi, M., & Okuda, K. (2006). Oral hygiene evaluation for effective oral care in preventing pneumonia in dentate elderly. Archives of Gerontology and Geriatrics, 43(1), 53-64. doi:10.1016/j.archger. 2005.09.002

Adachi, M., Ishihara, K., Abe, S., & Okuda, K. (2007). Professional oral health care by dental hygienists reduced respiratory infections in elderly persons requiring nursing care. International Journal of Dental Hygiene, 5(2), 69-74.

Bassim, C. W., Gibso, G., Ward, T., Paphides, B, M., & DeNucci, D.J. (2008). Modification of the risk of mortality from pneumonia with oral hygiene care. JAGS: The American Geriatric Society, 56, 1601-1607.

Bopp, M., Darby, M., Loftin, K. C., & Broscious, S. (2006). Effects of daily oral care with 0.12% chlorhexidine gluconate and a standard oral care protocol on the development of nosocomial pneumonia in intubated patients: A pilot study. Journal of Dental Hygiene, 80(3), 1-13.

Cutlerr, C, J., & Davis, N. (2005). Improving oral care in patients receiving mechanical ventilation. American Journal of Critical Care, 14(5), 389-394.

Feider, L.L., Mitchell, P. & Bridges, E. (2010). Oral care practices for orally intubated critically ill adults. American Journal of Critical Care, 19(2), 175-183.

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 Journal of Critical Care, 18(6), 523-532.

Munro, C. L., Grap, M. J., Elswick, R. K., McKinney, J., Sessler, C. N., & Hummel, R. S. (2006). Oral health status and development of ventilator-Associated pneumonia: A descriptive study. America Journal of Critical Care, 15(5), 453-460.

Quagliarello, V., Ginter, S., Han, L., Van Ness, P., Allore, H., & Tinetti, M. (2005). Modifiable risk factors for nursing home-acquired pneumonia. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 40(1), 1-6. Shariatzadeh, M, R., Huang, J, Q., & Marrie, T. J. (2006).

Differnces in the features of aspiration pneumonia according to site of acquisition: Community or continuing carefacility. JAGS: The American Geriatrics Society, 54, 296-302. Terpenning, M. (2005). Geriatric oral health and pneumonia risk. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 40(12), 1807-1810. Tintinalli, J. E. (2010).Tintinalli's emergency medicine: A comprehensive study guide. New York, NY: The McGraw-Hill Companies.

Watando, A., Ebihara, S., Ebihara, T., Okazaki, T., Takahashi, H., Asada, M., Sasak, H. (2005). Daily oral care and cough reflex sensitivity in elderly nursing home patients. Chest, 126(4), 1066-1070.

Yoneyama, T., Yoshida, M., Ohrui, T., Mukaiyama, H., Okamoto, H., Hoshiba, K., Ihara, S., Yanagisawa, S., Ariumi, S., Morita, T., Mizuno, Y., Ohsawa, T., Akagawa, Y., Hashimoto, K., Sasaki, H. (2002). Oral care reduces pneumonia in older patients in nursing homes. Journal of the American Geriatric Society, 50(3), 430-433.

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