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Assessing delirium: pragmatics and confounders


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1.Understanding when delirium can and cannot be assessed, and how sedatives make an accurate assessment more complicated
2.Understanding why different genetics, administering more than one drug or duration of sedative drug administration can change therapeutic effect and why it matters in the critically ill

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Assessing delirium: pragmatics and confounders

  1. 1. ASSESSING PAIN, SEDATION AND DELIRIUM: PRAGMATICS, PHARMACOKINETICS AND CONFOUNDERS November 19 2013 19 november 2013 ** All lines are muted upon entry. If you have any questions, please raise your hand or CHAT to Host **
  2. 2. Your Hosts & Presenters Vos hôtes & et présentateurs Dr. Denny Laporta, Chair Canadian ICU Collaborative Président, Collaboration canadienne des soins intensifs Bruce Harries, Collaborative Director Directeur de la Collaboration Dr. Yoanna Skrobik, Intensivist, Hôpital Maisonneuve Rosemont, Montréal Paule Bernier, SIA for Quebec Campaign (SHN) Conseillère en amélioration et sécurité, SSPSM (Québec) Ardis Eliason, Project Coordinator and Technical Host for today’s session Coordonatrice de projet et hôte technique Leanne Couves, Improvement Advisor and Moderator Conseillère en amélioration et Animateur 11/19/2013 2
  3. 3. Faculty Membres de la faculté Denny Laporta, MC, FRCPC Claudio Martin, MD, FRCPC Yoanna Skrobik, MD, FRCPC Paule Bernier, Dt.P., M.Sc. John Muscedere, MD, FRCPC Cathy Mawdsley, RN, M.Sc. Anne MacLaurin, Project Manager, Canadian Patient Safety Institute (CPSI) /Coordonatrice de projets, ICSP 11/19/2013 3
  4. 4. Interacting in WebEx: Today’s Tools Interagir dans Webex : outils à utiliser Have you used WebEx before? Avez-vous déjà utilisé WebEx?  YES / OUI NO / NON  Soyez prêts à Be prepared to use: utiliser les outils : - Pointer - le pointeur - Raise hand - lever la main - CHAT - clavardage - Text Tool - Outil textuel “writing on the slide” pour « écrire sur la diapo » - Shape Tools 11/19/2013 4 - Outils de forme Select ‘send to’ Type your message & click ‘send’
  5. 5. Who’s Online? Qui est en ligne? POINTER 11/19/2013 5
  6. 6. POINTER What professions are represented? Quelles professions sont représentées? Nurse/ infirmière Infection ControlPCI MD Educator /Éducateur Quality Improvement Professional/Professionnel en amélioarion de la qualité Administrator /Administrateur Senior Leader Psychiatry/ psychiatrie Other/ autre Pharmacy/ pharmacie 11/19/2013 6 6
  7. 7. Objectives But de l’appel  Comprendre quand délirium peut  Understand when delirium can et ne peut pas être évalué, et and cannot be assessed, and how comment les sédatifs compliquent sedatives make an accurate cette évaluation assessment more complicated  Comprendre pourquoi la  Understand why different génétique, la co-administration de genetics, administering more than plusieurs médicaments ou la durée one drug or duration of sedative de l'administration des sédatifs drug administration can change changent leur effet thérapeutique ; therapeutic effect and why it les aspects pertinents aux soins matters in the critically ill intensifs sont évalués 11/19/2013 7
  8. 8. Assessing pain, sedation and delirium: pragmatics, pharmacokinetics and confounders Dr. Yoanna Skrobik
  9. 9. Assessing pain, sedation and delirium: pragmatics, pharmacokinetics and confounders Yoanna Skrobik MD FRCP(c)
  10. 10. Yoanna Skrobik MD FRCP(c) And do we really care?
  11. 11. Conflicts of interest  Member, SCCM Pain, Agitation and Delirium guidelines writing committee  Investigator initiated research funding, Hospira  Academic chair, Université de Montréal
  12. 12. Academic chair Astellas Merck Pfizer Baxter Hospira Otsuka Novartis Lilly
  13. 13. assessing pain, sedation and delirium: pragmatics, pharmacokinetics and confounders        Introduction Pain scales and their importance The scales we use for sedation The scales we use for delirium Pharmacokinetics and their role in the continuum The confounders conclusion
  14. 14. assessing pain, sedation and delirium: pragmatics, pharmacokinetics and confounders Introduction: why you should care
  15. 15. why we should care (introduction) • Pain, Sedation and delirium monitoring are mandated on critical care wards for Canadian hospital accreditation • Sedatives and opiates are administered to many patients and more medications are administered in ICU than on most hospital wards • Excessive sedation is common, and is related to drug kinetics or interaction • This makes delirium screening challenging
  16. 16. Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in Adult Patients in the Intensive Care Unit Authors: Juliana Barr, MD, FCCM; Gilles L. Fraser, PharmD, FCCM; Kathleen Puntillo, RN, DNSc, FAAN; E. Wesley Ely, MD, MPH, FACP, FCCM; Céline Gélinas, RN, PhD; Joseph F. Dasta, MSc; Judy E. Davidson, DNP, RN; John W. Devlin, PharmD, FCCM; John P. Kress, MD; Aaron M. Joffe, DO; Douglas B. Coursin, MD; Daniel L. Herr, MD, MS, FCCM; Avery Tung, MD; Bryce RH Robinson, MD, FACS; Dorrie K. Fontaine, PhD, RN, FAAN; Michael A. Ramsay, MD; Richard R. Riker, MD, FCCM; Curtis N. Sessler, MD, FCCP, FCCM; Brenda Pun, RN, MSN, ACNP; Yoanna Skrobik, MD, FRCP; Roman Jaeschke, MD, MSc
  17. 17. ICU PAD Care Bundle
  18. 18. pain
  19. 19. Patient-directed pain control.
  20. 20. pain  Adult ICU patients, both medical and surgical, routinely experience pain, both at rest and with routine ICU care .  Pain in adult cardiac surgery patients, especially women, (i.e., incisional pain due to coughing, respiratory care procedures, and mobilization) remains prevalent and poorly treated .  Procedural pain is common in adult ICU patients .
  21. 21. patient evaluation standards
  22. 22. patient evaluation standards
  23. 23. patient evaluation standards
  24. 24. sedation
  25. 25. Monitoring sedation  The RASS and SAS scales are valid and reliable for measuring quality and depth of sedation in adult ICU patients .
  26. 26. Sedation-Agitation Scale (SAS) Score State Behaviors 7 Dangerous Agitation 6 Very Agitated 5 Agitated 4 Calm and Cooperative 3 Sedated 2 Very Sedated Arouses to physical stimuli but does not communicate or follow commands 1 Unarousable Minimal or no response to noxious stimuli, does not communicate or follow commands Pulling at ET tube, climbing over bedrail, striking at staff, thrashing side-to-side Does not calm despite frequent verbal reminding, requires physical restraints Anxious or mildly agitated, attempting to sit up, calms down to verbal instructions Calm, awakens easily, follows commands Difficult to arouse, awakens to verbal stimuli or gentle shaking but drifts off Riker RR, et al. Crit Care Med. 1999;27:1325-1329. Brandl K, et al. Pharmacotherapy. 2001;21:431-436.
  27. 27. Richmond Agitation Sedation Scale (RASS) Score State +4 Combative +3 Very agitated +2 Agitated +1 Restless 0 Alert and calm -1 Drowsy eye contact > 10 sec -2 Light sedation eye contact < 10 sec -3 Moderate sedation -4 Deep sedation -5 Unarousable Verbal Stimulus no eye contact physical stimulation no response even with physical Ely EW, et al. JAMA. 2003;289:2983-2991. Sessler CN, et al. Am J Respir Crit Care Med. 2002;166(10):1338-1344. Physical Stimulus
  28. 28. Sedation confounders
  29. 29. And now for a little pharmacology
  30. 30. Cytochrome P450
  31. 31. Some examples CYP 450 3A4/5: midazolam, fentanyl CYP 450 2D6: haloperidol, codeine, oxycodone, and tramadol CYP 2C19: propofol
  32. 32. Pharmacokinetics, dynamics and genetics  Is it relevant to ICU patients?
  33. 33. Drug-drug interactions
  34. 34. The Effect of Critical Illness on the Pharmacokinetics and Dose-Response Relationship of Midazolam Daniel Ovakim January 19, 2012
  35. 35. Results Patient Characteristics Table 1: Patient Characteristics and Study Details Variable Patients enrolled – no. 9 Age – mean +/- SD (range) 56.3 +/- 11 (33-72) Male sex – no. (%) 7 (78) Co-morbidities on admission – no. CHF 1 CKD 1 Hemodialysis 1 Chronic benzodiazepine use 0 Chronic ethanol use 2 Hepatic dysfunction 2 Condition on study enrollment APACHE II – mean +/- SD (range) 24 +/- 10 (7-43) Acute kidney injury – no. 4 GCS – mean +/- SD (range) 7 +/- 2 (3-14) GCS < 8 – no. (%) 6 (67%) Study details – mean +/- SD (range) Days in study 8.8 +/- 3.9 (3-14) Days on MDZ infusion 4.8 +/- 3.1 (1-11) Days in study off infusion 4.0 +/- 2.9 (0 -10) Days with GCS < 8 3.8 +/- 4.0 (0-12) GCS < 8 during study – no. (%) 7/9 (78)
  36. 36. Results Midazolam PK Table 3: Pharmacokinetic Parameters in Study Participants and Healthy Controls Study Patients Healthy Controls╪ PK Parameter Mean +/- SD Range Mean +/- SD Range CLss (mL/min) 418 +/- 324 31-1157 376 267-485 T½ (h) 16.0 +/- 9.6 2.3-34.9 3.2 1.0-4.0
  37. 37. Results Clearance at Steady-State (Css, mg/min) Midazolam Clearance 1400 1200 Clearance at Steady State 1000 800 600 400 200 0 0 1 2 3 4 5 6 7 8 9 Patient ID Figure 1: Observed intra- and intersubject variability in midazolam clearance at steady-state.
  38. 38. Pharmacodynamic Midazolam characteristics : It’s About Time • Highly lipid soluble • α-OH midazolam metabolite • CYP3A4 activity decreased in critical illness • Substantial CYP3A4 variability
  39. 39. Pharmacodynamic Midazolam characteristics : It’s About Time Carrasco G, et al. Chest. 1993;103:557-564. 60 40 Extubation Alertness Recovery 30 20 10 0 <1 1-7 >7 Sedation Time (days) Time to Endpoint (h) 50
  40. 40. Pharmacodynamic Midazolam characteristics : It’s About Time Bauer TM, et al. Lancet. 1995;346:145-147.
  41. 41. Why people develop coma
  42. 42.  100 patients
  43. 43. results
  44. 44. coma  Occurrence of coma not related to administered midazolam or fentanyl doses  Coma occurrence correlated with the coadministration of CYP3A4/5 inhibitors (p=0.0046) when adjusted for doses of fentanyl and midazolam
  45. 45. Coma and plasma levels of fentanyl
  46. 46. Coma and plasma levels of fentanyl
  47. 47. Coma and plasma levels of midazolam
  48. 48. Coma and the effect of CYP3A4/5 inhibitor coadministration
  49. 49. Bottom line • Validated scales include SAS, RASS and probably MASS • Ramsay and Glasgow not valid • These scales should drive lowering sedation over time or discontinuing it for longer periods • The longer you are on sedatives and the more combined drugs you receive the more likely you are to be ‘deep’
  50. 50. delirium Van der Mast. PhD Thesis, Delirium After Cardiac Surgery, Erasmus University, Rotterdam, 1994
  51. 51. Delirium scales ICDSC (Intensive Care Delirium Screening Checklist) CAM-ICU (Confusion Assessment Method-ICU)
  52. 52. Delirium diagnosis in the ICU: how hard can it be?
  53. 53. ICU Delirium diagnostic challenges  Standardized delirium screening in the ICU setting, and their inherent methodological flaw  Potential confounders
  54. 54. DSM IV criteria American Psychiatric Association, Diagnostic and Statistical Manual IV, American Psychiatric Press, Inc, Washington, DC, 1994
  55. 55. Confounders:  Other psychiatric diagnoses
  56. 56. Other psychiatric diagnoses  Delirium (10-80%)  Depression (35-45%)  Post-Traumatic stress disorder (35%)
  57. 57. Delirium incidence From 10% to > 85%  Intensive Care Med 27:1892-1900  JAMA 286:2703-2710  Crit Care Med 29:1370-1379  JAMA 291:1753-1762  Crit Care 5:265-270  Gen Hosp Psychiatry 17:371-379  Crit Care Med 32:2254-2259  J Am Geriatr Soc 51:591-598  Lancet 2010 Nov 27;376(9755):1829-37 …………..(10% of 6572 patients screened!)
  58. 58. wakefulness
  59. 59. DSM IV criteria American Psychiatric Association, Diagnostic and Statistical Manual IV, American Psychiatric Press, Inc, Washington, DC, 1994
  60. 60. The data when delirium is considered in the light of sedation level  CAM-ICU and RASS comparison: 69% of CAM-ICU positive assessments occurred in patients with a RASS ≤ 0  Over half of the patients with a RASS of -2 and 25% of those with a RASS -1 were considered not assessable  Among patients whose RASS scored changed more than two levels from the previous day, delirium with the CAM-ICU was five times more likely …..  Numerous studies support the sedation level-positive delirium screening relationship
  61. 61. Prevalence of delirium is a function of wakefulness Prevalence CAM-ICU positive (%) Sedated Wakeful Absolute Difference Riker 45-75 12 30 Ely 83 40 43 Haenggi 53 31 22 Poston 73 49 24 Gusmao-Flores 89 32 57 Patel ? ? 30 IF this is related to sedation, patients should transition from CAM positive to CAM negative when sedation is lightened Riker. CCM 2012; 40:1092 Haenggi. ICM 2013; epub Posten. AJRCCM 2010:A6701 Ely. JAMA 2001; 286:2703 Gusmao-Flores ICM 2013; epub Patel. AJRCCM 2013; 187:A5237
  62. 62. So what
  63. 63. Delirium is bad for you
  64. 64. Delirium and outcomes  Delirium is strongly associated with increased mortality and LOS in adult ICU patients.  Delirium is moderately associated with the development of post-ICU cognitive impairment in adult ICU patients.
  65. 65. Coma is bad for you
  66. 66. Probably not six of one…  of 102 ICU patients, coma or a positive CAM-ICU result were 10 times more likely to occur prior to sedation interruption .  Patients with “delirium” that cleared as sedation was lightened (termed “drug-related delirium”) had outcomes virtually identical and better than patients who never had delirium  This dramatic difference was consistent for ventilator-, ICU-, and hospital-free days and for one year mortality,
  67. 67. Sedation-related delirium and time on the ventilator, in the ICU and in the hospital
  68. 68. What now?
  69. 69. icdsc
  70. 70. 重症监护谵妄筛查表(第一版) 武汉市同济医院  4/8 or more corresponds to a delirium diagnosis
  71. 71. Intensive Care Delirium Screening Checklist (ICDSC) PATIENT EVALUATION Altered level of consciousness* (A-E) DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 If A or B do not complete patient evaluation for the period Inattention Disorientation Hallucination - delusion – psychosis Psychomotor agitation or retardation Inappropriate speech or mood Sleep/wake cycle disturbance Symptom fluctuation TOTAL SCORE (0-8) Bergeron, N. Dubois M.J. Skrobik, Y. Intensive Care Delirium Checklist : evaluation of a new screening tool. Intensive Care Medicine, 2001
  72. 72. icdsc  Of ICDSC’s 8 features “psychomotor slowing” should not be considered if this slowing is attributable to sedative administration  consciousness is recognized to be the least valid ICDSC component, particularly when the ICDSC is performed by nurses.
  73. 73. CAM ICU  The validity of the level of consciousness component has not been tested with the CAM-ICU to date.  Should probably stratify positive score by RASS (-1,0 or 1 vs. -2 or less)
  74. 74. Summary of confounders  Psychiatric diagnoses  Sedation level  Operationally it boils down to judgement :-)
  75. 75. In conclusion  Pain assessment is the first priority  Sedation should be validated with a reproducible scale  Deep sedation is a lot more likely the longer you have been on sedatives and the more simultaneously metabolized drugs you are on (especially if doses, even prn, are not titrated down)  Delirium assessment should be documented with simultaneous sedation score levels to ensure the data analysis can account for the sedation confounders subsequently  Other psychiatric diagnoses and their role remain unexplored
  76. 76. Thank you
  78. 78. “Taking the Pulse” Poll Sondage « prendre le pouls » 11/19/2013 86
  79. 79. Canadian ICU Collaborative Faculty Paule Bernier, P.Dt., Msc, Sir MB David Jewish General Hospital (McGill University), Montreal Paul Boiteau MD, Department Head, Critical Care Medicine, Alberta Health Services; Professor of Medicine, University of Calgary Leanne Couves, Improvement Advisor, Improvement Associates Ltd. Bruce Harries, Collaborative Director, Improvement Associates Ltd. Denny Laporta MD, Intensivist, Department of Adult Critical Care, Jewish General Hospital; Faculty of Medicine, McGill University Anne MacLaurin, Project Manager, Canadian Patient Safety Institute (CPSI) /Coordonatrice de projets, ICSP Claudio Martin MD, Intensivist, London Health Sciences Centre, Critical Care Trauma Centre; Professor of Medicine and Physiology, University of Western Ontario; Chair/Chief of Critical Care Western Cathy Mawdsley, RN, MScN, CNCC; Clinical Nurse Specialist – Critical Care, London Health Sciences Centre; John Muscedere MD, Assistant Professor of Medicine, Queens University; Intensivist, Kingston General Hospital 11/19/2013 87
  80. 80. Reminders Rappels  Call is recorded  Slides and links to recordings will be available on Safer Healthcare Now! Communities of Practice  Additional resources are available on the SHN Website and Communities of Practice 11/19/2013 88  L'appel est enregistré  Les diapositives et liens vers les enregistrements seront disponibles sur Des soins de santé plus sécuritaires maintenant! Communautés de pratique  Des ressources supplémentaires sont disponibles sur le site Web SSPSM et Communautés de Pratique
  82. 82. This National Call is hosted by: Supported by: 11/19/2013 90