The aim of this experimental study is to examine the effectiveness of adding toothbrushing to the usual oral care on the prevention of VAP in ICU patients. Objectives are: i. To explore the relationship between oral health status and the development of VAP in ICU patients. ii. To explore the relationship between oral care and the development of VAP in ICU patients. iii. To evaluate the effect of adding toothbrushng to the usual oral care on the prevention of VAP in ICU patients. iv. To identify a strategy for improving oral care so as to prevent VAP and to enhance quality of life of ICU patients.
Introduction VAP is hospital-acquired pneumonia that develops in an intubated patient after 48 hours or more of mechanical ventilation, and that was not present before intubaton (Fields, 2008).
The development of VAP is a concern and its prevention is essential because it is the most common nosocomial infection in mechanically ventilated patients and is a preventable consequence of intubation and mechanical ventilation (Barcaly & Vega, 2005).
In addition, it results in high mortality and morbidity, prolonged length of hospitalization and ICU stay, and increased cost of care (Kleiman & Boody, 2009).
As bacterial colonisation of oral cavity is one of critical risk factors for VAP (Munro et al, 2006) and oral care plays a vital role in preventing VAP (Munro et al, 2004), nurses, therefore, have a responsibility to ensure oral care effectively supplement the other strategies used to prevent VAP. Despite the importance of oral care in ICU has been noted, universal oral care standards do not exit and evidence-based oral care protocol for ICU have not been reported (Kleiman & Boody, 2009).
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Thus, a better designed procedural approach for oral care for ICU patients is needed. In this experimental study, the specific aim is to determine the effect of adding toothbrushing to the usual oral care on the prevention VAP in ICU patients. Theoretical perspective Paradigm is “a set of assumptions on which the research question are based” (Bowling, 2009 p129) which guides the investigator in choice of method, ontological and epistemologically fundamental ways (Guba & Lincoln, 1994), so that this may help with the structure/ format of a research.
The assumptions of paradigm include ontology which means ‘what is the nature of reality’; epistemology which means the relationship between researchers and researched; and methodology which means the process of research (Hatch, 2000).
In this proposal, the author try to uncover the effect of adding toothbrushinge to the usual oral care on the prevention of VAP in ICU patients and try to prove the effect is truth. For the nature of this reality is a single objective and external truth exists out there, it is a realist ontology.
For the effect is best investigated by an objective measurement and the relationship of the observed to the researcher in this study is detached and non-interactive standpoint, it is an objectivist epistemology. For the effect will be measured in term of rate of VAP via an experimental study, this data collecting method is called experimental methodology (Guba, 1990).
Therefore, a positivism paradigm will be more appropriate for this proposal. Literature Review Literature review is necessary and essential skill for researcher as it explains and justifies why the topic is chosen and its importance (Abbot, 1993).
In this proposal, literature search was conducted by using the keywords of “nosocomial pneumonia” or “ventilator-associated pneumonia”, and “oral hygiene” or “oral care” through the electronic databases: ProQuest, CINAL and PubMed in the electronic libraries of Hong Kong Hospital Authority (HKHA) and Oxford Brookes University. Besides searching by keyword, the publication year was restricted for ensuring up-dated information. The reference lists of those collected articles provided additional publication. VAP is defined as pneumonia that develops in an intubated patient after 48 hours or more of mechanical ventilation (Fields, 2008).
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It is the most common nosocomial infection in mechanically ventilated patients and is a preventable secondary consequence of intubation and mechanical ventilation (Barclay & Vega, 2005), so its development and prevention is a concern. Oral health is influenced by dental plaque, the oral microbial flora, and oral immunity (Munro et al, 2004).
Dental plaque is a biofilm found on tooth surfaces that provides a microhabitat for microorganisms (Munro et al, 2004).
Microbial flora is a complex environmental niche of interdependent microorganisms embedded in bacterial and salivary product, which are concentrated in dental plaque (Munro et al, 2004).
Thus, dental plaque may serve as a reservoir for pathogens in patients with poor oral hygiene (Blot et al, 2008), and critically ill patients may have preexisting poor oral health as their oral health may be compromised by medical conditions or treatment, ICU equipments, and their inability to attend oral care by their own (Tantipong et al, 2008).
Regarding the relationship between oral health status and the development of VAP, Scannapieo and colleagues found in 1992 that bacteria that normally cause pneumonia in hospitalised patients colonises the dental plaque and oral mucosa of the ICU patients and may occur in large number.
Although it may be considered as outdated study and selection bias may be suspected while recruiting participants from two different health status for comparison, similar result were found by Munro and colleagues in 2006. They performed a nonexperimental, longitudinal descriptive study on 66 patients, the study criteria included oral health status and the Clinical Pulmonary Infection Score (CPIS) assessed at baseline, determined at day 4 and day 7 post intubation.
Patients having history of intubation during the current hospitalisation were excluded for avoiding selection bias, because reintubation increased the risk of VAP. The CPIS assessment tool provided greater discrimination than categorical scoring system did. Researchers were trained and were periodically retested to maintain interrater reliabilities greater than 0. 9, which are objective measurement for minimizing measurement bias. The confounding factors- demographics data and severity of illness were collected and analysed by descriptive statistic.
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Hence, the finding “greater dental plaque scores confer greater risk for VAP particularly for patients with greater severity of illness” would be considered as reliable result. As bacteria colonisation in oral cavity has been identified as one of the risk factors for the development of VAP, oral care intervention should be considered as a preventive measure of VAP. ‘Oral care’ is the process of cleaning oral cavity to remove plaque from tooth surface and maintain moisture in oral cavity and mucous membranes, and its objective is to minimize dental plaque formation (Rello et al, 2007).
Although there are several reasons of not performing oral care by nurses, including low priority of care (O’Reilly, 2003), endotracheal tube limiting access to mouth (Grap et al, 2003), and it is difficult and unpleasant task (Cutler & Davis, 2005), oral care have to be considered as an essential basic nursing care for ICU patients as oral hygiene can reduce oral colonization (Fourrier et al, 1998), it plays a vital role in reducing VAP (Munro et al, 2004), and VAP carries a substantial health-economic burden (Cason et al, 2007).
However, universal oral care standards do not exit and evidence-based oral care protocol have not been reported (Kleiman & Boody, 2009).
For the need to standardise oral care have been substantiated, studying the effectiveness of different oral care interventions on the prevention of VAP is essential. According to Fields (2008), oral care including timed toothbrushing can mitigate and prevent the occurrence of VAP while combined with the VAP bundle.
This finding was seen as success as the author stated that the VAP rate dropped to zero per 1000 ventilator days within a week of beginning the study in the intervention group and was sustained for 6 months. The sample size measured in term of ventilated patients or ventilator days would be adjustable. The actual sample size was 345 patients (1850 ventilator days) seem adequate. A randomised controlled trial (RCT) was the original design, which may enhance internal validity (Polit & Beck, 2008).
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Randomised worksheets were used to allocate participants to which groups could enhance the success of the randomisation and guarantee suitable distribution across conditions (Polit & Beck, 2008).
The researcher biases could be eliminated while those participated group were managed the same via training, monitoring and documenting. However, the inadequate documentation by nurse was a confounding factor, and the final finding would not be considered as a reliable result for the RCT esign study had been changed as per management’s request. Permission for study was granted from the local review board was an ethical consideration but obtaining informed consent from participants or their families were not mentioned. The differences in the solution used for swabbing, the workload of nurses and the adequacy of equipment may be a variable but they were not mentioned. Additionally, in the study of Sona and colleagues (2009), the purpose was to determine the effects of a sample low-cost oral care protocol on VAP rate.
This preintervention and postintervention observational study was susceptible to bias due to unrecognised change in patient population or in ICU practices, while compare to a prospective, randomised trial. All admitted patients requiring mechanical ventilation represented the study population. Recruiting the sample size in term of ventilator days would be adjustable, and more than 4000 ventilator days in each intervention period seem as an adequate sample size.
However, including patients without teeth as sample could be a confounding factor as dental plaque, which is the factor of bacterial colonisation, may not be found in their oral cavity. Moreover, patients’ medical histories and present diagnose may be another confounding factor if recruiting sample without identifying specific criteria. The finding of 46% reduction of VAP was an objective outcome, and the P=0. 04 was considered as a low value and to be statistically significant (Glenny & Gibson in Craig & Smyth, 2007).
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But, the oral care practice in the preintervention period were not mentioned in the study may be a variable.
Regretfully, the VAP rate stated in the above research studies were tracked by their own hospital infection control department but they did not mention the measurement criteria for VAP. The nurse patient ratio which may be the potential variable impacting the outcome of the studies were not mentioned in the studies as well. For the combination of mechanical and chemical oral care intervention is significant in the prevention of VAP as stated previously, toothbrushing is a noninvasive and inexpensive intervention and the chemical oral care is the urrent practice in the study ICU, it is worth to perform a similar study in local population in respect of local need. In addition, evidence-based practice via research study is needed in order to ensure the quality of patient care, and it may provide a direction for larger-scale study in future. Methodology An experimental methodology, which is one of the positivist methodologies, will be chosen in this study to test the effect of adding toothbrushing to the usual oral care on the prevention of VAP in ICU patients.
For the outcome- the incidence of VAP, will be expressed in numbers, this study will be a quantitative study (Appleton in Neale, 2009).
A Randomized Controlled Trial (RCT) will be the best method for this study as it is a powerful experimental method for evaluating the effectiveness of an intervention and it can reduce confounding factors and selection bias (Smith & Ryan in Neale, 2009).
This reduction allows strong inferences about causality to be made and helps to ensure a study has high internal validity (Smith & Ryan in Neale, 2009).
However, this study has to be open (“non-blind”) as the researchers and participants tend to know that they have received an intervention (Bowling, 2009).
Methods The study will be conducted in an ICU of a regional hospital in Hong Kong with totally 26 beds from 1st March to 30th September 2011. This unit has about 2500 admission each year; approximately 75% of the admitted patients require mechanical ventilation (unpublished data, 2011).
A 2-groups pretest-posttest experimental design will be used. Assignment to groups will be determined by randomisation decided by the computer generated random table.
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One group (experimental group) receives the additional intervention- toothbrushing and the other group as a control of remaining the usual intervention (Brink & Wood, 1998).
Restricted randomisation by blocking will be used in order to ensure approximately the sample size in each group (Polit & Beck, 2004).
According to Mayhall (2001), VAP will be diagnosed if the following signs or symptoms appear at least 48 hours after mechanical ventilation and that was not present before intubation, Diagnostic criteria for VAP is,
Thus, data of body temperature, tracheal aspiration culture (which will be collected while performing tracheal suction to proivde tracheal clearance), blood tests for Leukocyte count and chest X-Ray will be collected within 24 hours intubation for both group as baseline measurement; and repeat measurement will be done every day until 5 days after intubation, or patient is extubated or is discharged from ICU. Changes from pretest to posttest that occurred in both group will be compared (Portney & Watkins, 2009).
Sample and Access to Sample By using the convenience sampling method, participants will be chosen on the base of availability for which is more practicable in the acute clinical setting (Portney & Watkins, 2009).
Participants will be recruited from all patients admit to the ICU who meet the following inclusive and exclusive criteria, Inclusive criteria are: |Inclusive Criteria |Rationale | |1. Who are over 18 years of age. Patient above this age is considered as an adult which is the target age group for | | |this study. | |2. Who are intubated within 24 hours |As VAP develops after 48 hours or more of mechanical ventilation, collecting data | | |within 24 hours of intubation as baseline to rule out other pneumonia. | |3. Who do not have a previous diagnosis |To ensure the validity of finding. | |of pneumonia. | | |4.
Who required mechanical ventilation |As VAP develops after 48 hours or more of mechanical ventilation (Dodek et al, | |for 48 hours or longer. |2004), follow-up data have to be collected more than 48 hours for comparison. | |5. Who or their relatives agree to |Respect for human dignity is one of main ethical principles (Polit & Hungler, 1999).
| |participate in this study. | | Exclusive criteria are: Exclusive Criteria |Rationale | |Who with prior tracheotomy |It is a confounding factor, as tracheotomy | | |is also a factor of pneumonia. | |Who are witnessed aspiration of vomitus or food. |It is a confounding factor, as aspiration | | |may lead to chemical pneumonia. | |Who are immunosuppressed (either HIV or drug induced e. . organ transplant, long |It is a confounding factor as patient with | |term steroid therapy).
|immune deficiency is at an increased risk | | |of pneumonia. | |Who already had had endotracheal intubation during the current hospital admission.
Re-intubation increases the risk for VAP | | |(Torres et al, 1995).
| |Whose chest X-Ray shown infiltrate, or an organism isolated from sputum or |These signs and symptoms present less than | |tracheal aspiration; and have two further symptoms, such as fever higher than 38. |48 hours of mechanical ventilation may not | |degree C, Leukocyte count >10,000mm3 or purulent tracheal secretions are |be considered as VAP (Dodek et al, 2004).
| |presented/ developed less than 48 hours of mechanical ventilation. | | Data collection Instruments: An experimental oral care set, include a small-headed toothbrush with suction hole, will be used for the experimental group which is based on the potential for easier oral access in intubated patients, despite the size of the toothbrush does not affect its ability to remove plaque (Hillam et al, 1994).
A usual oral care set, include Toothett and 0. 12% chlorhexidine gluconate, will be provide as usual for all control and experimental group. Intervention: For the control group, The usual oral care regime will be performed by nurses three times a day as usual, that is using a Toothette soaked with 0. 12% chlorhexidine, which is the most successful pharmacological agent reported at reducing plaque and gingivitis (Sona et al, 2009), to swab all teeth; oral soft tissues; and the floor of the mouth and tongue dorsum for two minutes. Excess rinse will be suctioned out after one minute.
For the experimental group, Toothbrushing will be added by using a suction toothbrush three times a day. All teeth and the surface of the tongue will be brushed for two minutes, rinse with tap water and then perform suction at completion and as needed during brushing. Thereafter, the usual oral care will be performed as same as the control group. Procedure: Baseline measurement, including body temperature, tracheal aspiration culture, blood for Leukocyte count and chest X-Ray, will be collected from all participants who meet the criteria within 24 hours intubation.
They, then, will be randomly assigned to 2 groups (control or experimental) by computer ordered. The usual oral care will be performed to the control, and adding toothbrushing to the usual oral care will be performed to the experimental group. Thereafter, repeat measurement will be done every day until 5days after intubation, or participant is extubated or is discharged from ICU. Finally, changes from pretest to posttes occurred in both group will be compared. A detailed data collection process is shown in Figure 1. Figure 1: Data Collection Process All participants’ demographics, admission diagnosis, duration of mechanical entilation, length of ICU stay, the incidence of VAP, the time of onset of VAP and causative bacteria will be recorded and compiled in a database on a computer. Data analysis The Statistical Package for Social Science (SPSS) 16. 0 will be used for data analysis in this study. Inferential statistics will be used to find relationships between variables. Independent samples t-test will be used to compare the 2 sets of data. Repeated measure analysis of variance (R-ANOVA) will be used to detect any significant differences in various parameters at different time intervals.
The level of significant will be set at P10,000/mm3 or purulent respiratory tract secretions are present. Baseline Measurement Data of body temperature, tracheal aspiration culture, blood for Leukocyte count and chest X-Ray will be collected within 24 hours intubation. Group Randomisation Control Group Usual oral care Experiment Group Toothbrushing + usual oral care Repeat Measurement Date of body temperature, tracheal aspiration culture, blood for Leukocyte count and chest X-Ray will be collected every day until 5 days after intubation, or patient is extubated or is discharged from ICU.
