Intensive and Critical Care Nursing
Volume 26, Issue 4 , Pages 189-195, August 2010

International variations in outcomes from sedation protocol research: Where are we at and where do we go from here?

  • Mark O’Connor

      Affiliations

    • Alfred Hospital Intensive Care Unit, Commercial Road, Prahran, Victoria, Australia
    • Corresponding Author InformationCorresponding author. Tel.: +61 3 93831453.
    • ,
  • Tracey Bucknall

      Affiliations

    • Cabrini/Deakin Centre for Nursing Research, Burwood, Victoria, Australia
    • ,
  • Elizabeth Manias

      Affiliations

    • Melbourne School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Level 5, 234 Queensberry Street, Carlton, Victoria 3053, Australia

Accepted 8 May 2010.

Article Outline

Summary 

In this article, sedation protocol research in the intensive care environment is critically examined, focusing upon the differences in outcomes from research conducted on mechanically ventilated patients in various countries. Limitations of the current research are discussed, with suggestions of how sedation protocol research may be conducted in future. Also, the monitoring of important clinical factors is discussed so that clinicians can assess the impact upon patients of changes to sedation management practices within their own ICU.

Keywords: Sedation, Protocol, Research, ICU

 

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Introduction 

In this commentary, sedation protocols are examined from an international viewpoint. Despite a considerable amount of recent research, there appears to be little consistency in sedation research outcomes, especially in different westernised intensive care units (ICUs). This article examines the results from sedation protocol trials and seeks to illuminate some of the reasons why different outcomes have occurred in seemingly similar experimental research. In addition, recommendations for future directions in sedation protocol research will be made.

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Background 

It is widely agreed that maintaining responsive and cooperative patients is preferable to stuporous or deeply sedated patients (Jacobi et al., 2002, Wunsch and Kress, 2009). Responsive and cooperative patients are better able to assist with their own recovery as they can participate in physiotherapy and are more likely to wean from mechanical ventilation support compared to those patients who are deeply sedated (Schweickert et al., 2009). However, it can be difficult to balance the unpredictable comforting effects of anxiolytics and analgesics with their sedating effects and the desire to keep patients awake and interactive.

Administration of sedatives and analgesics to intensive care patients can improve their tolerance to invasive supports and reduce physiological demands exerted by anxiety, agitation and pain. Commonly used medicines include propofol, benzodiazepines and opiates (Mehta et al., 2009, O’Connor et al., 2009). However, using these pharmacological agents in the ICU population can be problematic as there are risks of over-sedation (e.g. prolonged mechanical ventilation and hidden neurological deterioration) and under-sedation (e.g. pain or anxiety-induced hypertension and tachycardia). Additionally, anxiolytics and analgesics can have unpredictable effects caused by altered pharmacodynamics and pharmacokinetics in critically ill patients who can have multiple co-morbidities and organ dysfunction (Riker and Fraser, 2005, Swart et al., 2006, Wong et al., 2004).

Not surprisingly, intensive care clinicians have been searching for a gold-standard in sedation management with research failing to provide a clear cut answer. Some clinicians believe that their experience enables them to best judge patients’ sedative needs. Others believe that protocols will help to reduce variability in practices and better ensure a more objective method of managing patients’ needs (Sessler and Pedram, 2009). Indeed, sedation management protocols are more common in westernised ICUs now than a decade ago (Magarey, 1997, Mehta et al., 2009, O’Connor et al., 2009).

In the context of sedation management in ICU patients, protocols can be thought of as structured approaches, designed to guide clinicians’ decisions and stimulate standardised management of the patient's sedation needs based upon the clinically desired target for consciousness and the patient's response to treatment (Mehta et al., 2009, Sessler and Pedram, 2009). Sedation protocols often provide a decision-making algorithm and sometimes prescribe the dose and specific medicines to be administered according to subjective assessments of the patient's level of consciousness or degree of agitation (Brook et al., 1999, Bucknall et al., 2008, De Jonghe et al., 2005, Kress et al., 2000).

Unfortunately, the research on ICU patient outcomes when managed with sedation protocols compared to usual care has produced mixed results, denying clinicians a clear answer to this patient management problem. The aim of this paper is to examine some of the differences in sedation protocol research and to propose some explanations for these differences. Future directions for sedation protocol research are also explored.

Sedation protocol research 

In the last decade, many sedation protocol trials have been undertaken. Table 1 shows the key points of several sedation protocol studies from various countries. This section reviews the results of various key sedation protocol trials.

Table 1. Effects of sedation protocols in international studies.
Sedation/pain toolStudy designAPACHE II a SAPS II b Median [IQR] or ±SDControl/pre- and intervention/post-ventilation time (median days [IQR])Effects (p<0.05, unless stated)
Brook et al. (1999) (USA)Ramsay with protocol target=wakefulnessRCT of 321 MICU ptsa Control 23.2±SD 9.1
Int 23.1±SD 8.5		Control 124±SD 153.6
Int 89.1±SD 133.6hours		Reduced:
Vent time 28%, ICULOS by 30%
Control 5.17±6.4
Int 3.71±5.56 days		Tracheostomies by 53%
Kress et al. (2000) (USA)Ramsay with protocol target=wakefulness and DSI.RCT of 128 MICU ptsa Control 22 [IQR 16–25]
Int 20 [IQR 15–25]		Control 7.3 [3.4–16.1]
Int 4.9 [2.5–8.6]		Reduced:
Vent time 33%
ICU LOS by 35%, Neuro-diagnostic tests by 67%
MacLaren et al. (2000) (Canada)Aim for set modified Ramsay sedation scale score and modified visual-analogue pain scale=0=noneBefore–after study of 158 mixed ICU ptsa Pre 22.4±SD 8.3
Post 22.4±SD 7.0		Pre 162.5±SD 151
Post 205.8±SD 194.1hours		Increased:
Vent time by 20%
ICU LOS by 16%
Pre 6.8±SD 6.3
Post 8.75±SD 8.1 days		Reduced:
Ramsay scores representing discomfort by 51%
Visual-Analogue scores representing pain by 38%
Brattebo et al. (2002) (Norway)MAAS with protocol to ‘avoid excessive sedation’Before–after study of 285 SICU ptsb Pre 48.7±SD 16.4
Post 46.5±SD 14.9		Pre 7.4±SD 7.5
Post 5.3±SD 4.5		Reduced:
Vent time 28%
ICULOS, but not-sig
De Jonghe et al. (2005) (Canada)ATICE with algorithm target=wakefulnessProspective, two-phase study of 102 MICU ptsb Pre 50.6±SD 16.0
Post 47.9±SD 15.2		Pre 10.3 [3.5–17.2]
Post 4.4 [2.1–9.8]		Reduced:
Vent time 57%, ICULOS by 47%, Pressure sores by 50%
Chanques et al. (2006) (France)Systematic RASS, BPS & NRS evaluationsTwo-phase prospective controlled study of 230 mixed ICU pts.b Pre 32 [24–41]
Post 31 [21–41]		Pre 120 [48–312]
Post 65 [24–192]hours		Reduced:
Incidence of pain by 33%
Incidence of agitation by 59%
Pre 5 [2–13]
Post 2.7 [1–8] days		Vent time 45%, Nosocomial infections by 53%
ICULOS, but not-sig
Elliott et al. (2006) (Australia)Sedation algorithm, based on Ramsay score of 3 and subjective pain assessment.Before–after study of 322 mixed ICU ptsa Pre 21 [17–26]
Post 22 [17–27]		Pre 4.8 [2.1–9.2]
Post 5.6 [2.9–10.9]		Increased:
ICU LOS by 13%
Tracheostomies, but not-sig
No change:
Vent time
ETIC-7 (PTSD score)
Adam et al. (2006) (UK)Modified Ramsay with protocol target=wakefulnessBefore–after study of 3100 mixed ICU pts.a Pre 19 [16–23]
Post 20 [16–23]		c ICU LOS for non-cardiac ptsIncreased:
ICU LOS, but not-sig
Pre 4.6 (SD 4.4)
Post 5.1 (SD 4.3)		Reduced:
Costs of sedative medicines by 42%
Bucknall et al. (2008) (Australia)Sedation algorithm incorporating SASRCT of 312 surgical, trauma and medical ICU patientsa Control (mean) 19.5±SD 7.7
Int (mean) 18.6±SD 7.5		Control 58 [34–146]
Int 79 [35–152]hours		No change:
Vent time
ICU or hospital LOS
b Control (mean) 37.0±SD 15.4
Int (mean) 34.6±SD 15.1		Control 2.42 [1.5–6.1]
Int 3.3 [1.5–6.34] days		ICU or hospital mortality
Tracheostomy or self-extubation

Table 6 Adapted from Riker and Fraser (2007). RCT, randomised controlled trial; MICU, medical ICU; SICU, surgical ICU; ATICE, adaptation to the intensive care environment; LOS, length of stay; MAAS, motor activity assessment scale; BPS, behavioural pain scale; NRS, numerical rating scale; RASS, richmond agitation–sedation scale; ETIC-7, experience after treatment in intensive care 7 item scale; SAS, sedation–agitation scale.

aAPACHE II - Acute physiology and chronic health evaluation II.

bSAPS II - Simplified acute physiology score II.

cVentilation time not reported.

In a North American sedation protocol randomised controlled trial (RCT), Brook et al. (1999) demonstrated a shorter ICU length of stay (LOS) (5.7 versus 7.5 days, p=0.013) and shorter hospital LOS (14.0 versus 19.9 days, p<0.001) when comparing protocol directed sedation to routine sedation management in 321 medical ICU (MICU) patients. Similarly, a Canadian prospective cohort study (De Jonghe et al., 2005) produced dramatic reductions in ICU patients’ ventilation time (57%) and ICU LOS (47%) when a sedation assessment scale and management algorithm were introduced with the goal of patient ‘wakefulness’ (i.e. able to respond to closed commands).

In contrast, several sedation protocol trials have not shown demonstrable benefits to patient outcomes (Adam et al., 2006, Bucknall et al., 2008, Elliott et al., 2006). Elliott et al. (2006) replicated the Brook et al. (1999) American RCT in an Australian ICU setting using a before–after methodology on a sample of 322 mixed ICU patients. When comparing both studies, the patients had similar Acute Physiology and Chronic Health Evaluation II (APACHE II) scores (22–23), but there were differences in mean age (58 years old in Brook et al., 1999; 64–65 years old in Elliott et al., 2006) and patient heterogeneity (Elliott et al. included trauma and cardiac patients, compared to MICU patients only in Brook et al.). Elliott et al.’s study showed that the protocol introduction resulted in an increased ICU LOS (7.06 versus 8.16 days, p=0.04) and a slight (non-significant) increase in mechanical ventilation time.

Bucknall et al. (2008), in an Australian RCT of 312 mixed ICU patients, found that the introduction of a sedation protocol had no significant effect on ventilation time, length of stay or mortality. Similarly, this was also the case for Adam et al. (2006) in a before–after implementation trial of a sedation management guideline in a United Kingdom (UK) ICU. Adam et al. (2006) reported no difference in patient length of stay in ICU over the study period, but did report financial benefits to the protocol implementation due to a reduction in sedative use. MacLaren et al. (2000) used a before–after methodology to investigate the impact of a sedation protocol in a single Canadian ICU. Their results showed an increase in ICU LOS and ventilation time when patients were managed with a sedation protocol, but a reduction in indicators of pain and agitation.

Another trial in Canada by De Jonghe et al. (2005) showed a dramatic improvement in patient ventilation times and ICU LOS in a prospective, two-phase study of 102 MICU patients. De Jonghe et al. (2005) introduced a sedation assessment scale (Adaption to the Intensive Care Environment, ATICE) that they had previously developed in-house (De Jonghe et al., 2003) during the second phase of their study. Similar positive effects of a sedation protocol implementation have been recorded in Norway (Brattebo et al., 2002) and France (Chanques et al., 2006) (Table 1). Thus the research to date highlights the variation in results across settings which warrants further discussion.

Potential reasons for different outcomes across sedation protocol research 

Despite similarities in the overall experimental design of research trials, there are many reasons why there may be different outcomes from studies undertaken in various countries. These include variations in patient populations recruited into the study, differences in the models of ICU care and methodological limitations of the research (Endacott et al., 2010).

Intensive care patient populations are often compared with respect to outcome scoring systems, such as APACHE II, TISS or SAPS (Gunning and Rowan, 1999). These data are useful for comparative research purposes and quality improvement initiatives. However, these scoring systems have their limitations (Shann, 2000), such as the amount of variables they quantify and the lack of inclusion of the patient's clinical history before their ICU admission (Morris and Munro, 2009). APACHE II and SAPS, often used in the sedation trials documented in Table 1, assesses patients’ severity of illness in the first 24hours of ICU care only. As such, pre-ICU care and the changes in patients’ conditions over subsequent days are not acknowledged by the APACHE II or SAPS tools. Not all ICU patients follow a linear trajectory towards recovery after their admission day. It is possible that differences in patients’ severity of illness are not recorded in research studies due to this lack of monitoring over their ICU stay. As such, outcome prediction scores should be used cautiously when comparing clinical trials outcomes of different individuals being cared for in individual ICUs.

Further, given the intrinsic relationship between sedation and mental status, it would be useful to collate information on patients’ pre-admission mental status and their history of alcohol and psychoactive drug use. This information is rarely disclosed in sedation protocol trials even though alcohol dependent patients and those with substance abuse or mental health issues may make up a significant minority of ICU admissions (de Wit et al., 2007, O’Brien et al., 2007, Suchyta et al., 2008). Due to the illicit and hidden nature of substance abuse and mental illness, divulgence of these illnesses may not be forthcoming from patients or their significant others, making this information difficult to attain. Still, even though the differences in the proportion of patients with substance abuse or mental health issues between before–after or intervention-control groups may be minimal, this information is required so readers can assess the influence of these factors upon the study results.

Furthermore, models of care within each ICU need to be described in more detail so that readers can determine similarities to their own ICU practice environment. Variabilities can exist between nurse to patient ratios, nursing and medical specialisation and expertise, medical model of care (‘open’ or ‘closed’ ICUs, overnight staffing, consultant cover), the type and level of ICU, patient case-mix or the hospital location (Bellomo et al., 2007, Bucknall, 2003, McKinley, 2007, Rose et al., 2007). These differences may result in vast variations in patient outcomes. Many research manuscripts do not give detail on the level of staffing, their educational qualifications or the routines within the ICU where the research has taken place. This lack of reported detail may be due to the prudent use of limited word counts in peer-reviewed journals or a perceived lack of necessity for this information (by the authors or the journal editors) (Morris and Munro, 2009). Details on the context of the study is common in qualitative research (Schneider et al., 2003, p. 61) and the utility of this detail is now becoming more apparent in quantitative research also (Bellomo et al., 2009).

Notwithstanding, to suggest that differences in international models of intensive care may be a major factor in patient outcome differences may be over-simplifying the picture. Recent observation studies in Australia and past observation studies in Europe and North America have highlighted the vast differences in individual clinicians’ viewpoints and the complexities involved with decision-making and sedation management, even within single ICUs (Aitken et al., 2009, Bucknall et al., 2008, Egerod, 2002, O’Connor, 2008, Slomka et al., 2000, Weinert et al., 2001). ICU doctors’ and nurses’ autonomy and their individual ‘preferences’ may have significant impacts on patients’ treatment (Bucknall et al., 2008). Unfortunately, the impact of individual clinicians may have on individual patients may be difficult to quantify. For example, it may be difficult to quantify the impact that an individual nurse, working a single 8-hour shift, may have on the overall outcome of a patient who stays in ICU for 30 days. Similarly, individuals such as Medical Directors or Nurse Managers may have preferences that largely dictate sedation (and other) practices in some ICUs (O’Connor, 2008). But again, it would be difficult to evaluate the impact that these potentially beneficial or detrimental dictates may have on clinical practice and patient outcomes.

The most obvious methodological limitation in the current sedation protocol research is the use of single-centres to conduct trials (Bellomo et al., 2009). As Bellomo et al. (2009) illustrate, single-centre studies are essential to the progress of research as they allow for research protocols to be tested in the clinical setting, which may highlight potential problems that can be overcome in future multi-centre trials. However, these single-centre trials may provide data with limited generalisability and at their worst, may provide incorrect results when compared to subsequent multi-centred studies (Bellomo et al., 2009). We have previously argued that, at the time, the practice of daily sedation interruption (DSI) did not have a sufficient evidence base to justify inclusion in intensive care guidelines as it had only been tested in single-centres (O’Connor et al., 2008). Since that publication, the practice of DSI has been questioned after two small scale studies demonstrated potential risks to patients treated with DSI (de Wit et al., 2008, Mehta et al., 2008). Again, these two recent studies were undertaken in single-centres and therefore do not prove a causal relationship between DSI and (adverse) outcome. Nevertheless, these studies further re-iterate the need for multi-centre studies to confirm the safety and efficacy of potentially detrimental treatments in vulnerable patient groups.

A future direction of sedation protocol research 

Given the limitations of the current sedation protocol research and the lack of a clear direction for clinicians to take, there is a need for further high quality randomised controlled trials. International and national multi-centre trials, focused on reducing the potential for bias, are required if clinicians are to be reassured that a protocol can help them sedate their patient in the least-harmful manner. However, multi-centred studies are expensive, organisationally difficult to co-ordinate and therefore, may never be conducted to settle the argument. Clinicians must therefore look at their own practice and make collaborative decisions within their multi-disciplinary teams on whether an intervention, such as a sedation protocol, may be relevant to their own practice setting and beneficial to their patient group. In addition, ICU teams need to establish methods of monitoring protocol adherence and evaluating clinical impact (Bucknall et al., 2008). Chart audits, observation of practice and staff surveys are all methods of monitoring the success or failure of protocol implementation (Erdek and Pronovost, 2004), in addition to the important indicators of patients’ outcome, such as ventilation times, length of stay, adverse events and mortality, which are often collected in standardised formats and can be routinely reviewed.

Additionally, multi-centred observational studies would be useful to assist researchers and clinicians establish the subtle contextual differences, such as the communication between nurses and doctors, the characteristics of the patients, or the physical layout of an ICU, which may be just as relevant to patient outcome as a sedation management protocol (Bucknall, 2003, Bucknall et al., 2008, O’Connor, 2008).

Follow-up of ICU survivors’ recollections of pain, agitation and anxiety during their ICU experience is not currently standardised throughout westernised healthcare systems, although this practice is gaining popularity in countries such as the UK (Rattray and Crocker, 2007) and Europe (Jones, in press). Patient feedback from these follow-up assessments can be a potent reminder for clinicians that the stuporous, incapable bodies in the ICU bed, connected to multiple machines, might actually remember that experience (Magarey and McCutcheon, 2005). Unfortunately, medicine-induced amnesia does not appear to benefit patients in the long-term (Jackson et al., 2009, Jones et al., 1999, Kress et al., 2003) and so alternative and non-pharmacological therapies, such as massage, music, social interaction and environmental manipulation need further research to establish if they can positively alter patients’ memories of their ICU stay.

Whether through protocol implementation or goal-directed improvements in the ICU team's performance, the ultimate aim of sedation management is to improve the patients’ subjective experience during their critical illness and facilitate early discontinuation of invasive therapies. Factors such as unpredictable tolerance of medicines, or concomitant or chronic illness, such as alcohol dependence, may make these two goals incongruous sometimes, but through clinical expertise and team work, and possibly though protocol implementation, these negative aspects of patients’ sedative management can be minimised.

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Conclusion 

Optimal sedation management in critically ill patients is difficult and complex. Although some clinicians might use sedation protocols to standardise sedation management within ICU, they need to be aware that protocol implementation does not guarantee improvements in patient outcomes across all settings at this stage. As such, clinicians need to evaluate the effects of protocol implementation or alternatively use other measurable sedation management interventions to improve patient tolerance of invasive supports and hasten their ICU discharge.

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PII: S0964-3397(10)00039-X

doi:10.1016/j.iccn.2010.05.002

Intensive and Critical Care Nursing
Volume 26, Issue 4 , Pages 189-195, August 2010

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