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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 12, 2008 |
| Last Updated Date | March 12, 2008 |
| Start Date ICMJE | November 2004 |
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Event related Potentials (Amplitudes, latencies) at different clinically relevant sedation levels [ Time Frame: postoperative awakening ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | ERPS, BIS and Entropy for Neuromonitoring in ICU Patients |
| Official Title ICMJE | Auditory Event-Related Potentials, BIS-Index and Entropy for the Discrimination of Different Levels of Sedation in the ICU Patients |
| Brief Summary | Most critically ill patients receive sedative and analgesic drugs to attenuate discomfort and pain. The excessive use of sedatives and analgesics has undesirable effects for patients. Whereas undersedation is mostly easy to identify, oversedation with its associated problems is more difficult to recognize. Stopping sedation daily helps to avoid gross oversedation, but this is not always possible. Monitoring the depth of sedation is difficult and is currently based on clinical assessment and the use of clinical scoring systems. These scoring systems cannot be applied continuously, they are subjective and the level of consciousness can be altered when sedation is assessed. Several methods based on the electroencephalogram have been tested to avoid these problems, but the results have been disappointing so far, so the BIS Monitor an dthe Entropy monitor.We have previously shown that the time-locked cortical response to standard external stimuli (long-latency auditory evoked potentials or event-related potentials; ERPs) can discriminate between clinically relevant light to moderate and deep sedation levels in healthy volunteers, when sedation is induced with a combination of propofol or midazolam with remifentanil. We therefore hypothesized that ERPs may be used to monitor the depth of sedation in ICU patients as well. As the first step to test this hypothesis, we evaluated the use of ERPs to assess the level of sedation in patients undergoing elective major surgery and admitted to the ICU for short term postoperative mechanical ventilation. |
| Detailed Description | Most critically ill patients receive sedative and analgesic drugs to attenuate discomfort and pain. The excessive use of sedatives and analgesics prolongs time on mechanical ventilation, the incidence of nosocomial pneumonia, time spent in the intensive care unit, and increases costs. Strategies to reduce the use of sedatives and analgesics may improve the outcome. Whereas undersedation is mostly easy to identify, oversedation with its associated problems is more difficult to recognize, but should be avoided. While stopping sedation daily helps to avoid gross oversedation, this is not always possible, e.g. due to unstable condition of the patient. Also, accumulation of sedatives and analgesics may occur rapidly, especially in patients with renal and/or liver dysfunction. Monitoring the depth of sedation is difficult and is currently based on clinical assessment and the use of clinical scoring systems. These scoring systems cannot be applied continuously, they are subjective and the level of consciousness can be altered when sedation is assessed. Several methods based on the electroencephalogram have been tested to avoid these problems, but the results have been disappointing so far. A relatively new method of processed EEG is Entropy®. Entropy is a non-linear statistic parameter which describes the order of random repetitive signals. In patients it translates the anesthesia-induced "calmer", more synchronized EEG into a single parameter. Spectral entropy can reproducibly indicate the hypnotic effects of propofol, thiopental and different anesthetic gases. The most popular method of processed EEG for assessment of sedation is the bispectral index (BIS-Index®). While BIS has been tested and validated for the use in the operation room with different anesthetics, data on its use in the ICU setting at less deep levels of sedation are controversial. The multiple concomitant medications and heterogeneity of underlying pathologies present a further challenge to the use of neuromonitoring in the ICU. We have previously shown that the time-locked cortical response to standard external stimuli (long-latency auditory evoked potentials or event-related potentials; ERPs) can discriminate between clinically relevant light to moderate and deep sedation levels in healthy volunteers, when sedation is induced with a combination of propofol or midazolam with remifentanil. We therefore hypothesized that ERPs may be used to monitor the depth of sedation in ICU patients as well. As the first step to test this hypothesis, we evaluated the use of ERPs to assess the level of sedation in patients undergoing elective major surgery and admitted to the ICU for short term postoperative mechanical ventilation. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Case-Only, Prospective |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 20 |
| Completion Date | September 2007 |
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Switzerland |
| Administrative Information | |
| NCT ID ICMJE | NCT00639548 |
| Responsible Party | Haenggi Matthias, Department of Intensive Care Medicine - Inselspital |
| Study ID Numbers ICMJE | KIM-NMP4 |
| Study Sponsor ICMJE | University Hospital Inselspital, Berne |
| Collaborators ICMJE | GE Healthcare |
| Investigators ICMJE | |
| Information Provided By | University Hospital Inselspital, Berne |
| Verification Date | March 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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