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Corresponding author: Teresa Williams, ICU, Royal Perth Hospital, Wellington St, Royal Perth Hospital, Western Australia 6000 (e-mail: teresa.williams{at}health.wa.gov.au).
| Abstract |
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Objectives To evaluate outcomes before and after introduction of scales for sedation and analgesia in a general intensive care unit.
Method A before-and-after design was used to evaluate introduction of the Richmond Agitation-Sedation Scale and the Behavioral Pain Scale for patients receiving mechanical ventilation. Data were collected for 6 months before and 6 months after training in and introduction of the scales.
Results A total of 769 patients received mechanical ventilation for at least 6 hours (369 patients before and 400 patients after implementation). Age, scores on the Acute Physiology and Chronic Health Evaluation (APACHE) II, and diagnostic groups were similar in the 2 groups, but the after group had more men than did the before group. Duration of mechanical ventilation did not change significantly after the scales were introduced (median, 24 vs 28 hours). For patients who received mechanical ventilation for 96 hours or longer (24%), mechanical ventilation lasted longer after implementation of the scales (P =.03). Length of stay in the intensive care unit was similar in the 2 groups (P = .18), but patients received sedatives for longer after implementation (P=.01). By logistic regression analysis, APACHE II score (P <.001) and diagnostic group (P <.001) were independent predictors of mechanical ventilation lasting 96 hours or longer.
Conclusion Sedation and analgesia scales did not reduce duration of ventilation in an Australian intensive care unit.
| Achieving the appropriate balance of sedation and analgesia is challenging.
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Although ideal sedation varies from patient to patient, a common goal of sedation is to keep patients comfortable but easily rousable.5,6 This goal can be achieved by titrating the dose of the sedative agent to meet each patients objectives,2 which are agreed to by all caregivers to prevent different treatment goals7–9 and limit the risk of iatrogenic complications that could impede recovery.10 Achieving the appropriate balance of sedation and analgesia is challenging.11–13 If appropriately validated sedation and analgesia scales are used, a consistent level of sedation is more likely to be achieved, promoting patients comfort, facilitating a less-distressing ICU experience, and minimizing the duration of ventilatory support.14–17 The aim of this study was to evaluate patient-related outcomes before and after the introduction of a sedation scale and an analgesia scale; the primary outcome measure was duration of mechanical ventilation.
| Methods |
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Morphine and midazolam (usually given in a single syringe) or propofol infusions were the most frequently administered analgesic and sedative agents. No formal method of titration and monitoring of sedation was used before the introduction of the sedation and analgesia scales, and the decision to increase or decrease the level of sedatives administered to patients was most often left to the discretion of the bedside nurse. No daily interruption of sedation was used.
The Richmond Agitation-Sedation Scale (RASS)19 and the Behavioral Pain Scale (BPS)20 were selected to assess patients sedation and analgesia. These tools were selected on the basis of a consensus of expert clinicians (nurses and intensivists) working in the ICU. The RASS has been tested for reliability and validity19 and has been used in ICU studies.10,21 The BPS also has been tested for reliability and validity in French ICUs20 and an Australian ICU.22 The institutional ethics committee and the nursing research review committee approved the study.
| Definitions |
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Characteristics of patients and the sedatives and analgesics received by the before group (ie, before introduction of the scales) were collected for two 3-month data collection periods. Data were collected retrospectively from patients admitted to the ICU between September 1, 2003, and November 30, 2003, and prospectively for patients admitted from December 15, 2003, to March 12, 2004. Prospectively and retrospectively collected data were compared to see if a Hawthorne effect was apparent23; that is, if administration of sedatives changed because staff members were aware that they were being observed. Education was then provided to all staff, after which the sedation and analgesia scales were introduced. A 6-week delay between the start of training and the introduction of the scales gave the staff time to become familiar with the use of the scales in clinical practice. Evaluation of patients outcomes after the implementation of these scales for the after group was conducted from April 25, 2004, to October 21, 2004 (6 months).
Upon introduction of the scales, patients had a predefined target RASS score, based on their condition and tolerance of mechanical ventilation, documented by medical staff on the patients ICU flow charts. No formal protocol was used to direct drug administration to achieve the target RASS score. Bedside nurses recorded each patients level of sedation and analgesia hourly (by using the RASS and BPS), along with the patients score on the Glasgow Coma Scale and any movement by the patient. Bedside nurses and assessors formally assessed sedation and analgesia for every patient 4 times a day. Assessors were experienced senior ICU nurses trained in the use of the RASS and the BPS. The levels of sedation and analgesia were compared with predefined treatment goals. The assessment was performed when no procedures had been undertaken and no bolus doses of sedating medications had been administered within the previous 10 minutes. The time since the last activity and the type of activity also were documented.
In an effort to minimize effects of potential confounding factors, patients were not assessed for the first 6 hours after intubation, surgery, or other procedure requiring muscle relaxants or nonroutine sedation. A research nurse reviewed ICU flow charts to determine the mode and duration of mechanical ventilation, adverse events, amount of sedatives administered, and number of boluses of sedatives.
To test interrater reliability, randomly paired assessors assessed 25 patients before introduction of the scales. A bedside nurse stimulated each patient as part of routine care, and the assessors rated the patients level of sedation and analgesia concurrently but independently. Neither assessor provided care for the patient under assessment during the shift to avoid bias from uneven exposure.
Ratings given for sedation and pain were compared between the trained assessors before implementation of the scales; agreement between raters was high (
statistic, 0.98). Ratings of assessors and bedside nurses also agreed (within ±1), with the measure of agreement (
statistic) at 0.96 (P < .001).
A pilot study also was conducted for the first week to determine the feasibility and appropriateness of the data collection sheet. Small adjustments were made to data collection techniques. The results from this data collection were included in study results.
| The Richmond Agitation-Sedation Scale and the Behavioral Pain Scale were used.
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| Statistical Analysis |
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Categorical variables were compared by using the Pearson
2 test, and continuous variables were compared by using a t test for normally distributed data or nonparametric tests for nonnormally distributed data. Kaplan-Meier survival analysis was used to examine differences in duration of mechanical ventilation between groups. Logistic regression was used to test the independent effects of potential determinants, age, sex, before or after group, APACHE II score, and diagnostic group on the duration of mechanical ventilation, categorized as less than 96 hours or 96 hours and longer (short- and long-term mechanical ventilation). This time frame was chosen because it has been used before as the cutoff point to distinguish short- and long-term mechanical ventilation.25,26
| Sedation and analgesia were assessed for every patient 4 times a day.
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Variables were entered into the model by using backward elimination.27 The
statistic, a measure of agreement that corrects for agreement that occurs by chance, was used to test interrater reliability. Statistical analysis was performed with the SPSS version 14.0 computer software package (SPSS Inc, Chicago, Illinois).
All tests of significance were 2-sided, and significance levels were set at .05. A sample size of 142 patients was based on 80% power to detect a difference of 1.5 days (SD 4.5 days) in duration of mechanical ventilation between the before and after groups,
= .05 (2-tailed).28 The study was conducted for 12 months to ensure adequate recruitment and allow for patients who dropped out or were excluded.
| Results |
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62 =12.0; P =.06). A similar number of physical restraints was used before and after the intervention (z = 0.54; P = .59; 95% confidence interval for the difference in means, –0.06 to 0.04). The incidence of unplanned extubation was less in the after group, but the difference was not significant (2 unplanned extubations after implementation vs 7 before implementation, P = .07). Other adverse events were equally distributed between the 2 groups. Median (range) length of stay in the ICU was similar in the 2 groups: 2.3 (1.2–5.7) days before implementation versus 2.6 (1.1–6.8) days after implementation (z = 1.3; P = .18).
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| Discussion |
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| Duration of mechanical ventilation did not change after the scales were introduced.
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A difference was found between patients who did and did not have mechanical ventilation for 96 hours or longer (mechanical ventilation
96 hours: before group, 78 patients; after group, 104 patients). Age, sex, APACHE II score before and after intervention, and diagnostic group were important in univariate analysis, but not comorbid diseases, estimated on the basis of the chronic health evaluation points. Admission diagnosis and the APACHE II score contributed significantly to the duration of mechanical ventilation (<96 hours or
96 hours) after adjustment for confounders in the logistic regression models. Furthermore, a higher proportion of patients in the after group than in the before group received sedatives.
The most likely explanation for the lack of effect is that the scales complemented existing sedation and analgesia management in situations in which the duration of ventilation is already low compared with that of other ICUs. For example, median duration of mechanical ventilation in a study14 of 128 patients in the United States was 7.3 days in the control group. In a recent Australian study,30 duration of mechanical ventilation increased after introduction of a sedation algorithm, from 4.8 days to 5.6 days, supporting the view that ventilatory management in the closed ICU environment in Australia did not benefit from the addition of a universally applied objective assessment and protocol.
| A higher proportion of patients in the after group than in the before group received sedatives.
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Protocol-directed sedation reduces the duration of mechanical ventilation, ICU and hospital lengths of stay, and the need for tracheostomy among critically ill patients with acute respiratory failure,28 although these findings are not universal.31 Only a single report21 on the effect of introducing a sedation scale has been published. Although Chanques et al21 reported a reduction in the duration of mechanical ventilation in their study, similar to our study, they reported no difference in ICU length of stay. End points were different between the studies, and Chanques et al21 made no adjustment for possible confounding factors. Differences in case mix and severity of illness may explain the different outcomes.21 Although such differences are a limitation of before-and-after designs, this limitation may be partially overcome by multivariate analysis. After adjustment for age, sex, severity of illness, comorbid diseases, diagnosis, and before or after group, only the APACHE II score and diagnostic group were important determinants of mechanical ventilation of 96 hours or more.
Sedation and analgesia algorithms provide objective methods for managing sedation and pain levels in patients receiving mechanical ventilation.2 Use of sedation and weaning protocols that provide guidelines for the management of sedation probably influence outcomes rather than the specific choice of sedation or analgesia scale. However, in order to evaluate the benefit of these protocols, the contribution of introducing a sedation measurement tool should be understood. Changes to practice, such as daily wake-ups, can then be attributed to the practice change rather than to the scale used. In our study, the introduction of sedation and analgesia assessment scales did not confer any benefit in duration of mechanical ventilation and length of stay.
The study has several limitations. It was done at a single center, and therefore the results may not be generalizable to other units. However, the ICU is the largest in the state; it admits patients with a wide range of diseases and severity of illness and is similar to many ICUs of comparable size in Australia. The large sample size was achieved by collecting data for a 12-month period, thus providing sufficient power to account for exclusions (eg, patients receiving <6 hours of mechanical ventilation). The level of sedation may have been influenced by confounding factors such as interaction between sedation and analgesia, the patients condition, activity, extraneous noise, and circadian rhythms.32 However, assessments were done when no care activity had occurred for the previous 10 minutes and were done every 6 hours, day and night, minimizing the bias from these effects.
Selection bias may limit the validity of data on medication usage. Patients who had missing data on the use of sedatives were younger, sicker, had a longer length of stay in the ICU, and had longer duration of mechanical ventilation, but these differences were not significant. For patients who did have these data available, patients received sedatives for a longer period in the after group than in the before group, although length of stay in the ICU was similar between the 2 groups. This finding may indicate that patients in the before group did not receive adequate sedation and that the scales were useful in improving sedation /analgesia without an increase in the duration of mechanical ventilation. The greater use of sedatives also may be a consequence of inappropriate use of these scales to manage patients sedation.
Despite staff education before the introduction of the scales, staff members may have lacked skills in using these tools. However, in addition to staff education, senior nursing staff checked compliance with the tool daily, and interrater reliability was high (
= 0.98). Trained assessor and bedside nurses assessments were similar (
=0.96), so the tools most likely were used appropriately. Alternatively, the sedation and pain scales may have been inappropriate for this cohort. However, despite differences in case mix and severity of illness between ICUs, no reason suggests that results of previous studies cannot be applied to this critically ill cohort.
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FINANCIAL DISCLOSURES
This study was supported in part by a research grant from the Western Australian Nurses Memorial Charitable Trust.
Now that youve read the article, create or contribute to an online discussion about this topic using eLetters. Just visit www.ajcconline.org and click "Respond to This Article" in either the full-text or PDF view of the article.
To learn more about mechanical ventilation in critically ill patients, visit http://ccn.aacnjournals.org and read the article by Suzanne Burns, "Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome and Patients Requiring Weaning: The Evidence Guiding Practice" (Critical Care Nurse, August 2005).
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