Does an evidence-based sedation protocol improve practice and patient outcomes in critical care?

Learning Objective 1: compare protocol-directed sedation management with traditional non-protocol-directed practice in mechanically ventilated patients in an Australian critical care.

Learning Objective 2: explain the contrasting international research findings on sedation protocol implementation.
Minimization of sedation in critical care patients has recently received widespread support. Professional organizations internationally have published sedation management guidelines for critically ill patients to improve the use of research in practice, decrease practice variability and shorten mechanical ventilation duration. Innovations in practice have included the introduction of decision making protocols, daily sedation interruptions and new drugs and monitoring technologies. The aim of this study was to compare protocol-directed sedation management with traditional non-protocol-directed practice in mechanically ventilated patients in an Australian critical care setting.

A randomized, controlled trial design was used to study 312 mechanically ventilated adult patients in a general critical care unit at an Australian metropolitan teaching hospital. Patients were randomly assigned to receive protocol directed sedation management developed from evidence based guidelines (n=153) or usual clinical practice (n=159).

The median (95% CI) duration of ventilation was 58 hrs (44–78 hrs) for patients in the non-protocol group and 79 hrs (56–93) for those patients in the protocol group (p=0.20). Results were not significant for length of stay in critical care or hospital, the frequency of tracheostomies, and unplanned extubations. A Cox proportional hazards model estimated that protocol directed sedation management was associated with a 22% decrease (95% CI: 40% decrease to 2% increase, p=0.07) in the occurrence of successful weaning from mechanical ventilation.

Few randomized controlled trials have evaluated the effectiveness of protocol-directed sedation outside of North America. This study highlights the lack of transferability between different settings and different models of care. Qualified, high intensity nursing in the Australian critical care setting facilitates rapid, responsive decisions for sedation management and an increased success rate for weaning from mechanical ventilation.

General anaesthesia or conscious sedation for painful procedures in childhood cancer: the family's perspective

Background: Until recently, midazolam sedation was routinely used in our institution for bone marrow aspirates and lumbar punctures in children with cancer. It has been perceived by many doctors and nurses as being well tolerated by children and their families.

Aim: To compare the efficacy of inhalational general anaesthesia and midazolam sedation for these procedures.

Methods: A total of 96 children with neoplastic disorders, who received either inhalational general anaesthesia with sevoflurane, nitrous oxide, and oxygen (GA) or sedation with oral or nasal midazolam (SED) as part of their routine preparation for procedures were studied. The experiences of these childen were examined during their current procedure and during their first ever procedure. Main outcome measures were the degree of physical restraint used on the child, and the levels of distress and pain experienced by the child during the current procedure and during the first procedure. The family‘s preference for future procedures was also determined.

Results: During 102 procedures under GA, restraint was needed on four occasions (4%) when the anaesthetic mask was first applied, minimal pain was reported, and children were reported as distressed about 25% of the time. During 80 SED procedures, restraint was required in 94%, firm restraint was required in 66%, the child could not be restrained in 14%, median pain score was 6 (scale 0 (no pain) to 6 (maximum pain)), and 90% of the parents reported distress in their child. Ninety per cent of families wanted GA for future procedures. Many families reported dissatisfaction with the sedation regime and raised concerns about the restraint used on their child.

Conclusions: This general anaesthetic regime minimised the need for restraint and was associated with low levels of pain and distress. The sedation regime, by contrast, was much less effective. There was a significant disparity between the perceptions of health professionals and those of families with respect to how children coped with painful procedures.

Risk factors for impaired respiratory function during nurse-administered procedural sedation and analgesia in the cardiac catheterisation laboratory: a matched case-control study

Background
Side effects of the medications used for procedural sedation and analgesia in the cardiac catheterisation laboratory are known to cause impaired respiratory function. Impaired respiratory function poses considerable risk to patient safety as it can lead to inadequate oxygenation. Having knowledge about the conditions that predict impaired respiratory function prior to the procedure would enable nurses to identify at-risk patients and selectively implement intensive respiratory monitoring. This would reduce the possibility of inadequate oxygenation occurring.

Aim
To identify pre-procedure risk factors for impaired respiratory function during nurse-administered procedural sedation and analgesia in the cardiac catheterisation laboratory.

Design
Retrospective matched case–control.

Methods
21 cases of impaired respiratory function were identified and matched to 113 controls from a consecutive cohort of patients over 18 years of age. Conditional logistic regression was used to identify risk factors for impaired respiratory function.

Results
With each additional indicator of acute illness, case patients were nearly two times more likely than their controls to experience impaired respiratory function (OR 1.78; 95% CI 1.19–2.67; p = 0.005). Indicators of acute illness included emergency admission, being transferred from a critical care unit for the procedure or requiring respiratory or haemodynamic support in the lead up to the procedure.

Conclusion
Several factors that predict the likelihood of impaired respiratory function were identified. The results from this study could be used to inform prospective studies investigating the effectiveness of interventions for impaired respiratory function during nurse-administered procedural sedation and analgesia in the cardiac catheterisation laboratory.

Issues and challenges associated with nurse-administered procedural sedation and analgesia in the cardiac catheterisation laboratory: a qualitative study

Aims and objectives
To explore issues and challenges associated with nurse-administered procedural sedation and analgesia in the cardiac catheterisation laboratory from the perspectives of senior nurses.

Background
Nurses play an important part in managing sedation because the prescription is usually given verbally directly from the cardiologist who is performing the procedure and typically, an anaesthetist is not present.

Design
A qualitative exploratory design was employed.

Methods
Semi-structured interviews with 23 nurses from 16 cardiac catheterisation laboratories across four states in Australia and also New Zealand were conducted. Data analysis followed the guide developed by Braun and Clark to identify the main themes.

Results
Major themes emerged from analysis regarding the lack of access to anaesthetists, the limitations of sedative medications, the barriers to effective patient monitoring and the impact that the increasing complexity of procedures has on patients' sedation requirements.

Conclusions
The most critical issue identified in this study is that current guidelines, which are meant to apply regardless of the clinical setting, are not practical for the cardiac catheterisation laboratory due to a lack of access to anaesthetists. Furthermore, this study has demonstrated that nurses hold concerns about the legitimacy of their practice in situations when they are required to perform tasks outside of clinical practice guidelines. To address nurses' concerns, it is proposed that new guidelines could be developed, which address the unique circumstances in which sedation is used in the cardiac catheterisation laboratory.

Relevance to clinical practice
Nurses need to possess advanced knowledge and skills in monitoring for the adverse effects of sedation. Several challenges impact on nurses' ability to monitor patients during procedural sedation and analgesia. Preprocedural patient education about what to expect from sedation is essential.

Patient comfort in the intensive care unit : a multicentre, binational point prevalence study of analgesia, sedation and delirium management

Objective: To measure the prevalence of assessment and management practices for analgesia, sedation and delirium in patients in Australian and New Zealand intensive care units.
Materials and Methods: We developed survey items from a modified Delphi panel and included them in a binational, point prevalence study. We used a standard case report form to capture retrospective patient data on management of analgesia, sedation and delirium at the end of a 4-hour period on the study day. Other data were collected during independent assessment of patient status and medication requirements.
Results: Data were collected on 569 patients in 41 ICUs. Pain assessment was documented in the 4 hours before study observation in 46% of patients. Of 319 assessable patients, 16% had moderate pain and 6% had severe pain. Routine sedation assessment using a scale was recorded in 63% of intubated and ventilated patients. When assessed, 38% were alert and calm, or drowsy and rousable, 22% were lightly to moderately sedated, 31% were deeply sedated (66% of these had a documented indication), and 9% were agitated or restless. Sedatives were titrated to a target level in 42% of patients. Routine assessment of delirium occurred in 3%, and at study assessment 9% had delirium. Wrist or arm restraints were used for 7% of patients.
Conclusions: Only two-thirds of sedated patients had their sedation levels formally assessed, half had pain assessed and very few had formal assessment of delirium. Our description of current practices, and other observational data, may help in planning further research in this area.

A review of sedation scales for the cardiac catheterization laboratory.

Sedation scales have the potential to facilitate effective procedural sedation and analgesia in the cardiac catheterization laboratory (CCL). For this potential to become realized, a scale that is suitable for use in the CCL either needs to be identified or developed.

Clinical practice guidelines for nurse-administered procedural sedation and analgesia in the cardiac catheterization laboratory: a modified Delphi study

Aim : To develop clinical practice guidelines for nurse-administered procedural sedation and analgesia in the cardiac catheterization laboratory.

Background : Numerous studies have reported that nurse-administered procedural sedation and analgesia is safe. However, the broad scope of existing guidelines for the administration and monitoring of patients who receive sedation during medical procedures without an anaesthetist present means there is a lack of specific guidance regarding optimal nursing practices for the unique circumstances where nurse-administered procedural sedation and analgesia is used in the cardiac catheterization laboratory.

Methods : A sequential mixed methods design was used. Initial recommendations were produced from three studies conducted by the authors: an integrative review; a qualitative study; and a cross-sectional survey. The recommendations were revised according to responses from a modified Delphi study. The first Delphi round was completed by nine senior cardiac catheterization laboratory nurses. All but one of the draft recommendations met the predetermined cut-off point for inclusion with 59 responses to the second round. Consensus was reached on all recommendations.

Implications for nursing : The guidelines that were derived from the Delphi study offer 24 recommendations within six domains of nursing practice: Pre-procedural assessment; Pre-procedural patient and family education; Pre-procedural patient comfort; Intra-procedural patient comfort; Intra-procedural patient assessment and monitoring; and Postprocedural patient assessment and monitoring.

Conclusion : These guidelines provide an important foundation towards the delivery of safe, consistent and evidence-based nursing care for the many patients who receive sedation in the cardiac catheterization laboratory setting.

Protocol-directed sedation versus non-protocol-directed sedation to reduce duration of mechanical ventilation in mechanically ventilated intensive care patients (review)

Background : The sedation needs of critically ill patients have been recognized as a core component of critical care and meeting these is vital to assist recovery and ensure humane treatment. There is growing evidence to suggest that sedation requirements are not always optimally managed. Sub-optimal sedation incorporates both under- and over-sedation and has been linked to both short-term (e.g. length of stay) and long-term (e.g. psychological recovery) outcomes. Various strategies have been proposed to improve sedation management and address aspects of assessment as well as delivery of sedation.

Objectives : To assess the effects of protocol-directed sedation management on the duration of mechanical ventilation and other relevant patient outcomes in mechanically ventilated intensive care unit (ICU) patients. We looked at various outcomes and examined the role of bias in order to examine the level of evidence for this intervention.

Search methods : We searched the Cochrane Central Register of Controlled trials (CENTRAL) (2013; Issue 11), MEDLINE (OvidSP) (1990 to November 2013), EMBASE (OvidSP) (1990 to November 2013), CINAHL (BIREME host) (1990 to November 2013), Database of Abstracts of Reviews of Effects (DARE) (1990 to November 2013), LILACS (1990 to November 2013), Current Controlled Trials and US National Institutes of Health Clinical Research Studies (1990 to November 2013), and reference lists of articles. We re-ran the search in October 2014. We will deal with any studies of interest when we update the review.

Selection criteria : We included randomized controlled trials (RCTs) conducted in adult ICUs comparing management with and without protocol-directed sedation.

Data collection and analysis : Two authors screened the titles and abstracts and then the full-text reports identified from our electronic search. We assessed seven domains of potential risk of bias for the included studies. We examined the clinical, methodological and statistical heterogeneity and used the random-effects model for meta-analysis where we considered it appropriate. We calculated the mean difference (MD) for duration of mechanical ventilation and risk ratio (RR) for mortality across studies, with 95% confidence intervals (CI).

Main results : We identified two eligible studies with 633 participants. Both included studies compared the use of protocol-directed sedation, specifically protocols delivered by nurses, with usual care. We rated the risk of selection bias due to random sequence generation low for one study and unclear for one study. The risk of selection bias related to allocation concealment was low for both studies. We also assessed detection and attrition bias as low for both studies while we considered performance bias high due to the inability to blind participants and clinicians in both studies. Risk due to other sources of bias, such as potential for contamination between groups and reporting bias, was considered unclear. There was no clear evidence of differences in duration of mechanical ventilation (MD -5.74 hours, 95% CI -62.01 to 50.53, low quality evidence), ICU length of stay (MD -0.62 days, 95% CI -2.97 to 1.73) and hospital length of stay (MD -3.78 days, 95% CI -8.54 to 0.97) between people being managed with protocol-directed sedation versus usual care. Similarly, there was no clear evidence of difference in hospital mortality between the two groups (RR 0.96, 95% CI 0.71 to 1.31, low quality evidence). ICU mortality was only reported in one study preventing pooling of data. There was no clear evidence of difference in the incidence of tracheostomy (RR 0.77, 95% CI 0.31 to 1.89). The studies reported few adverse event outcomes; one study reported self extubation while the other study reported re-intubation; given this difference in outcomes, pooling of data was not possible. There was significant heterogeneity between studies for duration of mechanical ventilation (I2 = 86%, P value = 0.008), ICU length of stay (I2 = 82%, P value = 0.02) and incidence of tracheostomy (I2 = 76%, P value = 0.04), with one study finding a reduction in duration of mechanical ventilation and incidence of tracheostomy and the other study finding no difference.

Authors' conclusions : There is currently insufficient evidence to evaluate the effectiveness of protocol-directed sedation. Results from the two RCTs were conflicting, resulting in the quality of the body of evidence as a whole being assessed as low. Further studies, taking into account contextual and clinician characteristics in different ICU environments, are necessary to inform future practice. Methodological strategies to reduce the risk of bias need to be considered in future studies.

Sedation protocols to reduce duration of mechanical ventilation in the ICU: a Cochrane Systematic Review

AIMS: Assess the effects of protocol-directed sedation management on the duration of mechanical ventilation and other relevant patient outcomes in mechanically ventilated intensive care unit patients. BACKGROUND: Sedation is a core component of critical care. Sub-optimal sedation management incorporates both under- and over-sedation and has been linked to poorer patient outcomes. DESIGN: Cochrane systematic review of randomized controlled trials. DATA SOURCES: Cochrane Central Register of Controlled trials, MEDLINE, EMBASE, CINAHL, Database of Abstracts of Reviews of Effects, LILACS, Current Controlled Trials and US National Institutes of Health Clinical Research Studies (1990-November 2013) and reference lists of articles were used. REVIEW METHODS: Randomized controlled trials conducted in intensive care units comparing management with and without protocol-directed sedation were included. Two authors screened titles, abstracts and full-text reports. Potential risk of bias was assessed. Clinical, methodological and statistical heterogeneity were examined and the random-effects model used for meta-analysis where appropriate. Mean difference for duration of mechanical ventilation and risk ratio for mortality, with 95% confidence intervals, were calculated. RESULTS: Two eligible studies with 633 participants comparing protocol-directed sedation delivered by nurses vs. usual care were identified. There was no evidence of differences in duration of mechanical ventilation or hospital mortality. There was statistically significant heterogeneity between studies for duration of mechanical ventilation. CONCLUSIONS: There is insufficient evidence to evaluate the effectiveness of protocol-directed sedation as results from the two randomized controlled trials were conflicting.

Effects of methadone, alone or in combination with acepromazine or xylazine, on sedation and physiologic values in dogs

Objective To evaluate the effects of methadone, administered alone or in combination with acepromazine or xylazine, on sedation and on physiologic values in dogs.Study design Randomized cross-over design.Animals Six adult healthy mixed-breed dogs weighing 13.5 +/- 4.9 kg.Methods Dogs were injected intramuscularly with physiologic saline (Control), or methadone (0.5mg kg(-1)) or acepromazine (0.1 mg kg(-1)) or xylazine (1.0 mg kg(-1)), or acepromazine (0.05 mg kg(-1)) plus methadone (0.5 mg kg(-1)) or xylazine (0.5 mg kg(-1)) plus methadone (0.5 mg kg(-1)) in a randomized cross-over design, with at least 1-week intervals. Sedation, pulse rate, indirect systolic arterial pressure, respiratory rate (RR), body temperature and pedal withdrawal reflex were evaluated before and at 15-minute intervals for 90 minutes after treatment.Results Sedation was greater in dogs receiving xylazine alone, xylazine plus methadone and acepromazine plus methadone. Peak sedative effect occurred within 30 minutes of treatment administration. Pulse rate was lower in dogs that received xylazine either alone or with methadone during most of the study. Systolic arterial pressure decreased only in dogs receiving acepromazine alone. When methadone was administered alone, RR was higher than in other treatments during most of the study and a high prevalence of panting was observed. In all treatments body temperature decreased, this effect being more pronounced in dogs receiving methadone alone or in combination with acepromazine. Pedal withdrawal reflex was absent in four dogs receiving methadone plus xylazine but not in any dog in the remaining treatments.Conclusions Methadone alone produces mild sedation and a high prevalence of panting. Greater sedation was achieved when methadone was used in combination with acepromazine or xylazine. The combination xylazine-methadone appears to result in better analgesia than xylazine administered alone. Both combinations of methadone/sedative were considered effective for premedication in dogs.

Influence of sedation on morbidity and mortality in the intensive care unit

CONTEXTO: Embora cerca de 30% a 50% dos pacientes hospitalizados em unidades de terapia intensiva (UTI) recebam algum tipo de sedativo, existe escassez de informações sobre efeitos adversos desta prática, especialmente no Brasil. Estes efeitos podem ser significantes e o uso de sedativos é associado a elevação de infecção e mortalidade, mesmo sendo difícil avaliar o impacto clínico deste procedimento. OBJETIVO: Avaliar o impacto da sedação sobre incidência de complicações e mortalidade em doentes graves durante internação em unidade de terapia intensiva. TIPO DE ESTUDO: Estudo prospectivo. LOCAL: Unidade de Terapia Intensiva Cirúrgica da Universidade Federal de São Paulo (UNIFESP) - Escola Paulista de Medicina. PARTICIPANTES: Após excluídos pacientes que permaneceram menos de 24 horas ou sem exames indispensáveis para o cálculo do índice de gravidade (APACHE II), restaram 307 pacientes. Estes foram divididos em dois grupos: Grupo Sedado e Grupo Não Sedado. Constatada heterogeneidade com relação ao APACHE II, foram pareados 97 sedados e 97 não sedados com idênticos índices de gravidade. VARIÁVEIS ESTUDADAS: Impacto da sedação e das técnicas sobre a mortalidade, tempo de internação, além da incidência de escara de decúbito ou pressão, trombose venosa profunda e infecção. RESULTADOS: Não houve diferença na incidência de trombose venosa profunda, entre os grupos Sedado e Não Sedado, enquanto que escara de decúbito foi significativamente maior nos sedados (p = 0,03). Infecção foi detectada em 45,4% dos pacientes com sedação e em 21,6% dos pacientes sem sedação (p = 0,006). A mortalidade para os pacientes que não receberam qualquer tipo de sedativo foi de 20,6% e, para aqueles que foram sedados durante a internação, foi de 52,6% (p < 0,0001). CONCLUSÕES: Conclui-se que a sedação está associada a maior duração da internação, morbidade e mortalidade significativas. Apesar da intensidade das associações encontradas, não é possível estabelecer relação causal entre sedação e mortalidade.