title: A randomized controlled proof-of-concept trial of early sedation management using Responsiveness Index monitoring in mechanically ventilated critically ill patients.
abstract: BACKGROUND
  Deep sedation is associated with adverse patient outcomes. We recently described a novel sedation-monitoring technology, the Responsiveness Index (RI), which quantifies patient arousal using processed frontal facial EMG data. We explored the potential effectiveness and safety of continuous RI monitoring during early intensive care unit (ICU) care as a nurse decision-support tool.
  
  
  METHODS
  In a parallel-group controlled single centre proof of concept trial, patients requiring mechanical ventilation and sedation were randomized via sequential sealed envelopes following ICU admission. Control group patients received hourly clinical sedation assessment and daily sedation holds; the RI monitor was connected but data were concealed from clinical staff. The intervention group received control group care, but RI monitoring was visible and nurses were asked to adjust sedation to maintain patients with an RI>20 whenever possible. Traffic-light colour coding (RI<20, Red; 20-40, Amber; >40, Green) simplified decision-making. The intervention lasted up to 48 hours. Sixteen nurses were interviewed to explore their views of the novel technology.
  
  
  RESULTS
  We analysed 74 patients treated per protocol (36 intervention; 38 control). The proportion of patients with RI<20 was identical at the start of monitoring (54% both groups). Overall, the proportion of time with RI<20 trended to lower values for the intervention group (median 16% (1-3rd quartile 8-30%) versus 33% (10-54%); P = 0.08); sedation and analgesic use was similar. A post hoc analysis restricted to patients with RI<20 when monitoring started, found intervention patients spent less time with low RI value (16% (11-45%) versus 51% (33-72%); P = 0.02), cumulative propofol use trended to lower values (median 1090 mg versus 2390 mg; P = 0.14), and cumulative alfentanil use was lower (21.2 mg versus 32.3 mg; P = 0.01). RASS scores were similar for both groups. Sedation related adverse event rates were similar (7/36 versus 5/38). Similar proportions of patients had sedation holds (83% versus 87 %) and were extubated (47% versus 44%) during the intervention period. Nurses valued the objective visible data trends and simple colour prompts, and found RI monitoring a useful adjunct to existing practice.
  
  
  CONCLUSIONS
  RI monitoring was safe and acceptable. Data suggested potential to modify sedation decision-making. Larger trials are justified to explore effects on patient-centred outcomes.
  
  
  BACKGROUND
  NCT01361230 (registered April 19, 2010).
authors.affiliation: GE Healthcare Finland Oy, Kuortaneenkatu 2, 00510, Helsinki, Finland. markus.kaila@ge.com.
authors.forename: Markus
authors.initials: M
authors.lastname: Kaila
authors.affiliation: Anaesthetics, Critical Care and Pain Medicine, Centre for Inflammation Research and School of Clinical Sciences, Edinburgh University, 51 Little France Crescent, Edinburgh, Scotland, EH16 4SA, UK. kirstyeveringham@msn.com.
authors.forename: Kirsty
authors.initials: K
authors.lastname: Everingham
authors.affiliation: GE Healthcare Finland Oy, Kuortaneenkatu 2, 00510, Helsinki, Finland. Petteri.Lapinlampi@ge.com.
authors.forename: Petteri
authors.initials: P
authors.lastname: Lapinlampi
authors.affiliation: GE Healthcare Finland Oy, Kuortaneenkatu 2, 00510, Helsinki, Finland. Petra.Peltola@ge.com.
authors.forename: Petra
authors.initials: P
authors.lastname: Peltola
authors.affiliation: GE Healthcare Finland Oy, Kuortaneenkatu 2, 00510, Helsinki, Finland. mika.sarkela@med.ge.com.
authors.forename: Mika O K
authors.initials: MO
authors.lastname: Särkelä
authors.affiliation: GE Healthcare Finland Oy, Kuortaneenkatu 2, 00510, Helsinki, Finland. kimmo.uutela@med.ge.com.
authors.forename: Kimmo
authors.initials: K
authors.lastname: Uutela
authors.affiliation: Anaesthetics, Critical Care and Pain Medicine, Centre for Inflammation Research and School of Clinical Sciences, Edinburgh University, 51 Little France Crescent, Edinburgh, Scotland, EH16 4SA, UK. twalsh@staffmail.ed.ac.uk.
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Walsh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016292:Procedural Sedation / Q000379:methods*; D056805:Consciousness Monitors; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D012121:Respiration, Artificial / Q000379:methods*