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      A New ICU Delirium Prevention Bundle to Reduce the Incidence of Delirium: A Randomized Parallel Group Trial

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          A bstract

          Introduction

          Although various preventive strategies have been advocated, delirium is common in critically ill patients and is associated with increased morbidity, mortality, and long-term adverse effects. The efficacy of a novel delirium prevention bundle in mechanically ventilated critically ill patients was investigated in this study.

          Methods

          In this randomized controlled trial, 50 mechanically ventilated adult patients in a tertiary care medical-surgical intensive care unit (ICU) were randomized to receive either delirium prevention bundle protocol or standard of care protocol. Delirium was assessed daily using the Confusion Assessment Method for the ICU (CAM-ICU) score by an independent investigator up to 28 days or death or discharge. The primary outcome was the incidence of new-onset delirium. Secondary outcomes were duration of mechanical ventilation, ICU length of stay (ICU-LOS), hospital LOS, and other adverse events.

          Results

          There was a 20% reduction in the incidence of delirium in the intervention group (36 vs 56%; p = 0.156). The 28-day mortality (28 vs 24%; p = 0.747), duration of mechanical ventilation (9 vs 12 days; p = 0.281), ICU-LOS (11 vs 12 days; p = 0.221), and hospital LOS (16 vs 20 days; p = 0.062) were similar between the groups.

          Conclusion

          Implementation of delirium prevention bundle does not reduce the incidence of delirium compared to standard of care protocol in mechanically ventilated critically ill patients.

          How to cite this article

          Malik AK, Baidya DK, Anand RK, Subramaniam R. A New ICU Delirium Prevention Bundle to Reduce the Incidence of Delirium: A Randomized Parallel Group Trial. Indian J Crit Care Med 2021;25(7):754–760.

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          Most cited references29

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          Long-term cognitive impairment after critical illness.

          Survivors of critical illness often have a prolonged and disabling form of cognitive impairment that remains inadequately characterized. We enrolled adults with respiratory failure or shock in the medical or surgical intensive care unit (ICU), evaluated them for in-hospital delirium, and assessed global cognition and executive function 3 and 12 months after discharge with the use of the Repeatable Battery for the Assessment of Neuropsychological Status (population age-adjusted mean [±SD] score, 100±15, with lower values indicating worse global cognition) and the Trail Making Test, Part B (population age-, sex-, and education-adjusted mean score, 50±10, with lower scores indicating worse executive function). Associations of the duration of delirium and the use of sedative or analgesic agents with the outcomes were assessed with the use of linear regression, with adjustment for potential confounders. Of the 821 patients enrolled, 6% had cognitive impairment at baseline, and delirium developed in 74% during the hospital stay. At 3 months, 40% of the patients had global cognition scores that were 1.5 SD below the population means (similar to scores for patients with moderate traumatic brain injury), and 26% had scores 2 SD below the population means (similar to scores for patients with mild Alzheimer's disease). Deficits occurred in both older and younger patients and persisted, with 34% and 24% of all patients with assessments at 12 months that were similar to scores for patients with moderate traumatic brain injury and scores for patients with mild Alzheimer's disease, respectively. A longer duration of delirium was independently associated with worse global cognition at 3 and 12 months (P=0.001 and P=0.04, respectively) and worse executive function at 3 and 12 months (P=0.004 and P=0.007, respectively). Use of sedative or analgesic medications was not consistently associated with cognitive impairment at 3 and 12 months. Patients in medical and surgical ICUs are at high risk for long-term cognitive impairment. A longer duration of delirium in the hospital was associated with worse global cognition and executive function scores at 3 and 12 months. (Funded by the National Institutes of Health and others; BRAIN-ICU ClinicalTrials.gov number, NCT00392795.).
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            The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients.

            Sedative medications are widely used in intensive care unit (ICU) patients. Structured assessment of sedation and agitation is useful to titrate sedative medications and to evaluate agitated behavior, yet existing sedation scales have limitations. We measured inter-rater reliability and validity of a new 10-level (+4 "combative" to -5 "unarousable") scale, the Richmond Agitation-Sedation Scale (RASS), in two phases. In phase 1, we demonstrated excellent (r = 0.956, lower 90% confidence limit = 0.948; kappa = 0.73, 95% confidence interval = 0.71, 0.75) inter-rater reliability among five investigators (two physicians, two nurses, and one pharmacist) in adult ICU patient encounters (n = 192). Robust inter-rater reliability (r = 0.922-0.983) (kappa = 0.64-0.82) was demonstrated for patients from medical, surgical, cardiac surgery, coronary, and neuroscience ICUs, patients with and without mechanical ventilation, and patients with and without sedative medications. In validity testing, RASS correlated highly (r = 0.93) with a visual analog scale anchored by "combative" and "unresponsive," including all patient subgroups (r = 0.84-0.98). In the second phase, after implementation of RASS in our medical ICU, inter-rater reliability between a nurse educator and 27 RASS-trained bedside nurses in 101 patient encounters was high (r = 0.964, lower 90% confidence limit = 0.950; kappa = 0.80, 95% confidence interval = 0.69, 0.90) and very good for all subgroups (r = 0.773-0.970, kappa = 0.66-0.89). Correlations between RASS and the Ramsay sedation scale (r = -0.78) and the Sedation Agitation Scale (r = 0.78) confirmed validity. Our nurses described RASS as logical, easy to administer, and readily recalled. RASS has high reliability and validity in medical and surgical, ventilated and nonventilated, and sedated and nonsedated adult ICU patients.
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              Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit.

              To revise the "Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult" published in Critical Care Medicine in 2002. The American College of Critical Care Medicine assembled a 20-person, multidisciplinary, multi-institutional task force with expertise in guideline development, pain, agitation and sedation, delirium management, and associated outcomes in adult critically ill patients. The task force, divided into four subcommittees, collaborated over 6 yr in person, via teleconferences, and via electronic communication. Subcommittees were responsible for developing relevant clinical questions, using the Grading of Recommendations Assessment, Development and Evaluation method (http://www.gradeworkinggroup.org) to review, evaluate, and summarize the literature, and to develop clinical statements (descriptive) and recommendations (actionable). With the help of a professional librarian and Refworks database software, they developed a Web-based electronic database of over 19,000 references extracted from eight clinical search engines, related to pain and analgesia, agitation and sedation, delirium, and related clinical outcomes in adult ICU patients. The group also used psychometric analyses to evaluate and compare pain, agitation/sedation, and delirium assessment tools. All task force members were allowed to review the literature supporting each statement and recommendation and provided feedback to the subcommittees. Group consensus was achieved for all statements and recommendations using the nominal group technique and the modified Delphi method, with anonymous voting by all task force members using E-Survey (http://www.esurvey.com). All voting was completed in December 2010. Relevant studies published after this date and prior to publication of these guidelines were referenced in the text. The quality of evidence for each statement and recommendation was ranked as high (A), moderate (B), or low/very low (C). The strength of recommendations was ranked as strong (1) or weak (2), and either in favor of (+) or against (-) an intervention. A strong recommendation (either for or against) indicated that the intervention's desirable effects either clearly outweighed its undesirable effects (risks, burdens, and costs) or it did not. For all strong recommendations, the phrase "We recommend …" is used throughout. A weak recommendation, either for or against an intervention, indicated that the trade-off between desirable and undesirable effects was less clear. For all weak recommendations, the phrase "We suggest …" is used throughout. In the absence of sufficient evidence, or when group consensus could not be achieved, no recommendation (0) was made. Consensus based on expert opinion was not used as a substitute for a lack of evidence. A consistent method for addressing potential conflict of interest was followed if task force members were coauthors of related research. The development of this guideline was independent of any industry funding. These guidelines provide a roadmap for developing integrated, evidence-based, and patient-centered protocols for preventing and treating pain, agitation, and delirium in critically ill patients.
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                Author and article information

                Journal
                Indian J Crit Care Med
                Indian J Crit Care Med
                IJCCM
                Indian Journal of Critical Care Medicine : Peer-reviewed, Official Publication of Indian Society of Critical Care Medicine
                Jaypee Brothers Medical Publishers
                0972-5229
                1998-359X
                July 2021
                : 25
                : 7
                : 754-760
                Affiliations
                [1–4 ]Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Delhi, India
                Author notes
                Rajeshwari Subramaniam, Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Delhi, India, Phone: +91-1126593212, e-mail: drsrajeshwari@ 123456gmail.com
                Author information
                https://orcid.org/0000-0002-9229-8208
                https://orcid.org/0000-0001-7811-7039
                https://orcid.org/0000-0002-7852-1231
                https://orcid.org/0000-0002-3830-5278
                Article
                10.5005/jp-journals-10071-23881
                8286373
                34316168
                8b10ae81-7b90-4771-bfce-74db27acf04a
                Copyright © 2021; Jaypee Brothers Medical Publishers (P) Ltd.

                © Jaypee Brothers Medical Publishers. 2021 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and non-commercial reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Categories
                Original Article

                Emergency medicine & Trauma
                delirium,intensive care unit,mechanical ventilation
                Emergency medicine & Trauma
                delirium, intensive care unit, mechanical ventilation

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