Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor

Study Overview
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Brief Summary
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Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can be used for lot of disease like acute respiratory distress syndrome, septic shock. Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3. Deep sedation can be associated with increased mortality, length stay, duration of mechanical ventilation, acute brain dysfunction. The french exploration neurologic group in ICU developed a score used Brainstem response patterns in patient deeply sedated by midazolam and showed that a high BRASS score is associated with high mortality at day 28. The investigators think that BRASS score isn't associated with the medication used for sedation. In this study the investigators included all patients sedated independently of medication used for sedation, we also excluded patient with neurologic disorder. The main objective is to shown that high BRASS score at admission of patient without neurologic disorder sedated is predictive of 28-day mortality.

Detailed Description
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Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can be used for lot of disease like acute respiratory distress syndrome, septic shock. Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3. Deep sedation can be associated with increased mortality, length stay, duration of mechanical ventilation, acute brain dysfunction. The french exploration neurologic group in ICU developed a score used Brainstem response patterns in patient deeply sedated by midazolam and showed that a high BRASS score is associated with high mortality at day 28. The investigators think that BRASS score isn't associated with the medication used for sedation. In this study the investigators included all patients sedated independently of medication used for sedation, we also excluded patient with neurologic disorder. The main objective is to shown that high BRASS score at admission of patient without neurologic disorder sedated is predictive of 28-day mortality. The BRASS score will be done in the 6 hours within admission. The Richmond Assessment Sedation Scale (RASS) and Full Outline of unresponsiveness (FOUR) will be performed. The patient characteristic's will be recorded (sex, age, Simplified Acute Physiology Score II (SAPS II), medical or surgical admission, diagnosis at ICU admission (ARDS, sepsis,…), the reason of initiation of mechanical ventilation, the reason of sedation (agitation, analgesia, asynchrony with ventilator). The medication for sedation and the level at time of examination, the time between admission and examination will be recorded. For the outcome, the duration of mechanical ventilation, the duration of sedation administration, the occurrence of delirium evaluated by Confusion Assessment Method- intensive care unit (CAM-ICU), the length stay in ICU, death at day 28 and 90 will be reported.

Official Title
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Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor

Conditions
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Brainstem Response

Intervention / Treatment
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* Other: BRASS score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient more than 18 years Hospitalized in ICU Without neurologic disorder and/or neurologic pattern Under sedation and mechanical ventilation Exclusion Criteria: Patients with legal protection No affiliation with the French Health Care system Ongoing pregnancy Inability to obtain consent Not to resuscitate decision Neurologic disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with mechanical ventilation and sedation<br>All patient hospitalized in intensive care under sedation and mechanical ventilation without neurologic disorder | Other: BRASS score<br>* Brainstem response on neurologic examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality within 28 days after ICU admission | percentage of patients who died within 28 days after admission | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality within 90 days after ICU admission | percentage of patients who died within 90 days after admission | 90 days | 
| ICU Stay | mean of duration of ICU stay | 6 months | 
| Delirium | percentage of patients with delirium | 6 months | 
| duration on mechanical ventilation | mean of duration of mechanical ventilation | 6 months |