Susan Becker DNP, RN, CNS, CCRN, CCNS Marymount University, Arlington, VA
Disclosures Study and presentation has no commercial bias or interests No financial relationship with a commercial interest, products, or services Objectives Discuss the negative outcomes when using traditional medications for MV patients Describe the implementation of an extubation protocol using dexmedetomidine. Analyze the statistical results of the implementation study
Acknowledgements Duke University Lisa Day RN, PhD Barbara Turner RN, PhD Julie Thompson PhD Phyllis Kennel Sentara Northern Virginia Medical Center Richard Robinson M.D. Mark Clinton M.D. Gary Spanik BSPharm, RPh
Problem While on the ventilator, patients are uncomfortable - require traditional sedation such as propofol, lorazepam, or midazolam. Traditional sedation is turned off to prevent respiratory depression so that the patient can participate in the weaning process. Without sedation, some patients become anxious, developing tachypnea and tachycardia, and fail the extubation trial. (Riker et al, 2009)
Background/Significance Delirium - 85% of ICU patients may experience, increases morbidity and mortality Benzodiazepines associated with 60-80% delirium rates (9-23% ventilator-associated pneumonia) Long hospitalizations on mechanical ventilation (MV) cause increase 20% additional days due to decrease strength and motor function for 3-6 months. Riker et al, 2009
Solution Dexmedetomidine Highly selective α2-adrenergic receptor agonist Induces anxiolysis Sedates Has analgesic affects Does not cause respiratory depression
Relevant Studies SEDCOM Trial (Riker et al, 2009) Dexmedetomide vs Midazolam for Sedation of Critically Ill Patients Randomized, double-blind, 68 centers, 5 countries (March 05-Aug. 07) Level I N=375 med/surg ICU pt. on mechanical ventilation (MV) for > 24 hrs. Objective: To compare the efficacy and safety of prolonged sedation with dexmedetomide vs midazolam on vented pts. Outcome: With dexmedetomide, less time on MV, less delirium, less tachycardia, more bradycardia
MENDS Trial (Pandharipande et al, 2010) Effect of Dexmedetomidine vs Lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized control trial Randomized, double-blind septic vs non-septic pts. (Aug. 04-May06) adjusted covariates Level I N=103 (63 w/sepsis, 40 without) Hypothesis: Sedation with dexmedetomidine compared to lorazepam would improve clinical outcomes among septic more than non-septic pts. Outcome: more days free of delirium, fewer vent days, decrease in mortality, and greater benefit seen for the septic pt.
(Venn, Hell, & Grounds, 2000) Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care Randomized, double-blind, placebo-controlled, retrospectively analyzed Level II N=33 Goal: to analyze the respiratory effects of dexmedetomidine on vent pts. Outcome: No adverse effects on respiration.
(Snapir et al, 2006) Effects of low and high plasma concentrations of dexmedetomidine on myocardial perfusion and cardiac function in healthy male subjects Convenience, healthy males level II N=12 Goal: to determine the effects of therapeutic and high concentrations of dexmedetomide on myocardial perfusion and cardiac function in healthy subjects. Outcome: high concentration of dexmedetomide did not seriously affect myocardial perfusion or induce myocardial ischemia.
Use of dexmedetomidine for primary sedation in a general intensive care unit Systematic review of correlational/observational studies Level III N=42 Goal: dexmedetomidine reduces duration of vent days Outcome: pts receiving dexmedetomidine were calm, stable, weaned quicker than pts on midazolam or propofol. (Short, 2010)
Clinical Question: Would patients who are difficult to extubate benefit from the use of dexmedetomidine either alone or in combination with traditional sedation by having fewer ventilator days within a 3 month trial period?
Aim To implement and evaluate the effect of an evidence-based protocol initiating intravenous dexmedetomidine to sedate MV patients who are having difficulty with extubation. The success of the protocol implementation was measured by MV LOS.
Study Design Pre/Post Outcomes measured quantitatively by the mean LOS ventilator days Compared ICU pre-initiation of the innovation ventilator days to the postintervention ventilator days
Data The patients receiving dexmedetomidine, dosage amounts, Richmond Agitation Sedation Scale (RASS), and the number of successful extubations were recorded and trended. Other sedation or analgesics were required, medications given and the frequency of administration were noted. Adverse reactions and any need to discontinue the use of dexmedetomidine prior to extubation were documented. Data obtained using EMR
Organizational Setting 183 Bed Hospital 15 Bed ICU with Medical, Surgical, and Cardiac patients 5 Pulmonologists CNS Deployed pharmacist on unit (M-F)
The Innovation Use of dexmedetomidine Alternative medication - sedative & analgesic without respiratory depression. To be initiated when considering a difficult extubation of a patient. Does not need to be discontinued when a patient is extubated, providing continuation of tranquility and fostering a successful transition off mechanical ventilation (Siobal, Kallet, Kivett, & Tang, 2006).
Inclusion Adults Patients in the ICU appropriate to wean off MV Exclusion Pediatric Symptomatic bradycardia
Linkage Respiratory Therapists Administrators ICU RNs Innovator Pulmonologists Pharmacists
Implementation Education Physicians Special Care Committee meetings, 1:1 ICU Nurses Team meetings, huddles, e-mails Respiratory Therapists Team meetings Pharmacists Assessment Daily Multidisciplinary Rounds (MDRs) Conferred with Pulmonologists
Protocol No Bolus! Start infusion at 0.2 mcg/kg/hr. Do not titrate for first 30 minutes Then titrate at 0.1 mcg/kg/hr. (max 1mcg/kg/hr.) to keep RASS +1 to -2 May use additional sedatives/narcotics
Fact Sheet
Adverse Reactions Fever/chills, Nausea/vomiting Dry mouth Dysrhythmias Hyperglycemia Atelectasis Agitation Brought to the immediate attention of the pulmonologist.
Discontinuation Continued symptomatic bradycardia despite treatment Hypovolemia Hypoxia Physicians discretion
Results 15 patients Mean age - 60.13 9 Males/ 6 Female 2.13 Mean days on dexmedetomidine 3 patients were also on propofol and lorazepam 2 patients given analgesics (morphine) Decrease in mean MV LOS by 0.36 days per patient (ρ = 0.620) Adverse reactions - none
Results Pre Implementation Post Implementation Dexmedetomidine protocol N 94 118 15 MV LOS 473 543 118 Mean MV LOS 4.99 (SD = 0.726) 4.63 (SD = 0.498) 8.06 (SD = 5.56 )
Analysis Non-parametric test Mann-Whitney U-Test Effect size Mann-Whitney U 2.000 Wilcoxon W 8.000 Z -1.091
Limitations Small sample size One site Three months Hesitation to use a new protocol deviating from routine practice
Discussion Mean LOS for MV was 8.06 for the dexmedetomidine patients - longer than the average either pre (µ= 4.99) or post (µ=4.63). This result requires further investigation because there was no corresponding control group
Discussion (con t) Of the 15 patients, 13 (87%) were successfully weaned off MV while on dexmedetomidine 5 patients eventually died (one was terminally weaned)
Final analysis - trend of LOS days on MV declining after implementation of the dexmedetomidine protocol
Sustainability EMR order sets updated to reflect safer practice evidence-based standards Daily MDRs continue to assess suitability for dexmedetomidine use.
Future Studies Larger sample size Multi-institutional Longer interval to acquire data Other indications Maintenance on MV patients Alcohol withdrawal protocol Limiting PTSD during MV
Conclusion The use of dexmedetomidine was successfully implemented at the study site The trend, though not statistically significant, was noted to be decreasing in MV LOS for ICU patients on MV. Dexmedetomidine was found to be a safe, effective alternative to traditional sedation for difficult to extubate patients in ICU.
Questions