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Walsh T.S.,Royal Infirmary | Lapinlampi T.P.,GE Healthcare Finland Oy | Ramsay P.,Royal Infirmary | Sarkela M.O.K.,GE Healthcare Finland Oy | And 2 more authors.
British Journal of Anaesthesia | Year: 2011

Background. Excessive sedation is associated with adverse patient outcomes during critical illness, and a validated monitoring technology could improve care. We developed a novel method, the responsiveness index (RI) of the frontal EMG. We compared RI data with Ramsay clinical sedation assessments in general and cardiac intensive care unit (ICU) patients. Methods. We developed the algorithm by iterative analysis of detailed observational data in 30 medical-surgical ICU patients and described its performance in this cohort and 15 patients recovering from scheduled cardiac surgery. Continuous EMG data were collected via frontal electrodes and RI data compared with modified Ramsay sedation state assessments recorded regularly by a blinded trained observer. RI performance was compared with Entropy™ across Ramsay categories to assess validity. Results. RI correlated well with the Ramsay category, especially for the cardiac surgery cohort (general ICU patients ρ=0.55; cardiac surgery patients ρ=0.85, both P<0.0001). Discrimination across all Ramsay categories was reasonable in the general ICU patient cohort [P K=0.74 (SEM 0.02)] and excellent in the cardiac surgery cohort [P K=0.92 (0.02)]. Discrimination between 'lighter' vs 'deeper' (Ramsay 1-3 vs 4-6) was good for general ICU patients [P K=0.80 (0.02)] and excellent for cardiac surgery patients [P K=0.96 (0.02)]. Performance was significantly better than Entropy™. Examination of individual cases suggested good face validity. Conclusions. RI of the frontal EMG has promise as a continuous sedation state monitor in critically ill patients. Further investigation to determine its utility in ICU decision-making is warranted. © The Author [2011]. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved.


Kaskinoro K.,Intensive Care | Kaskinoro K.,University of Turku | Maksimow A.,Intensive Care | Maksimow A.,University of Turku | And 7 more authors.
British Journal of Anaesthesia | Year: 2011

Background The bispectral index (BIS) and the spectral entropy (state entropy, SE, and response entropy, RE) are depth-of-anaesthesia monitors derived from EEG and have been developed to measure the effects of anaesthetics on the cerebral cortex. We studied whether they can differentiate consciousness from unconsciousness during increasing doses of three different anaesthetic agents. Methods Thirty healthy male volunteers aged 1930 yr were recruited and divided into three 10-volunteer groups to receive either dexmedetomidine, propofol, or sevoflurane in escalating concentrations at 10 min intervals until loss of consciousness (LOC) was reached. Consciousness was tested at 5 min intervals and after drug discontinuation at 1 min intervals by requesting the subjects to open their eyes. LOC was defined as unresponsiveness to the request and pre-LOC as the last meaningful response. The first meaningful response to the request after drug discontinuation was defined as regaining of consciousness (ROC). For the statistical analysis, pre-LOC and ROC values were pooled to represent the responsive state while LOC values represented the unresponsive state. Prediction probability (PK) was estimated with the jack-knife method. Results The lowest mean values for BIS, SE, and RE were recorded at LOC with all three drugs. The PK values were low for dexmedetomidine (BIS 0.62, SE 0.58, RE 0.59), propofol (BIS 0.73, SE 0.72, RE 0.72), and sevoflurane (BIS 0.70, SE 0.52, RE 0.62). Conclusions Because of wide inter-individual variability, BIS and entropy were not able to reliably differentiate consciousness from unconsciousness during and after stepwise increasing concentrations of dexmedetomidine, propofol, and sevoflurane. © 2011 The Author.


Grant
Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2009.5.3 | Award Amount: 4.22M | Year: 2011

Traumatic brain injury (TBI) occurs when a sudden trauma causes damage to the brain it is a major health problem and the most common cause of permanent disability in people under the age of 40 years. Yearly cost from TBI in Europe exceeds 100 billion euros. Recent statistics show a steep increase in the incidence of TBIs, with an increase of 21 % over the last five years threefold greater than the rate of increase in population. Despite this TBI has been seriously underrepresented in medical R&D efforts compared to many other, less significant health problems.\nTBIcare project provides such an objective and evidence-based solution for management of TBI by improving diagnostics and treatment decisions for an individual patient. A strictly evidence-based approach realises the objectives of developing: 1) a methodology for finding efficient combinations of multi-modal biomarkers used in statistical models to objectively diagnose and assess an individual TBI patient, and 2) a simulation model for objectively predicting outcome of the planned treatment of an individual TBI patient. These objectives are supplemented by realization of: a software solution to be used in daily practice to diagnose and plan treatments; new approaches for extracting information from multi-source and multi-scale physiological databases for management of an extremely heterogeneous disease; and innovative data quantification methods for the clinical TBI environment. Thus, TBIcare transfers the scientific Virtual Physiological Human (VPH) concepts to clinical practice.\nTBIcare has impacts for healthcare professionals by improving the healthcare process and increasing medical knowledge; for the patients and their nearest by increased quality adjusted life years; for society it brings reduction in healthcare costs and losses due to working disability, and for the European industry it brings an impetus to increased global competitiveness by providing immediately exploitable innovative methods.


PubMed | Edinburgh Health Services Research Unit, GE Healthcare Finland Oy and University of Edinburgh
Type: Journal Article | Journal: BMJ open | Year: 2016

To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs).8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis.Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period.The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured.Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed.The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex interventions on sedation-analgesia quality. Recruitment is complete and analysis ongoing.NCT01634451.


Kaila M.,GE Healthcare Finland Oy | Everingham K.,University of Edinburgh | Lapinlampi P.,GE Healthcare Finland Oy | Peltola P.,GE Healthcare Finland Oy | And 3 more authors.
Critical Care | Year: 2015

Introduction: 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. Trial registration:NCT01361230(registered April 19, 2010) © 2015 Kaila et al.


PubMed | GE Healthcare Finland Oy and University of Edinburgh
Type: | Journal: Critical care (London, England) | Year: 2015

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.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.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.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.NCT01361230 (registered April 19, 2010).

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