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

Completed
Conditions
Brainstem Response
Interventions
Other: BRASS score
Registration Number
NCT03835091
Lead Sponsor
CHU de Reims
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
110
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patient with mechanical ventilation and sedationBRASS scoreAll patient hospitalized in intensive care under sedation and mechanical ventilation without neurologic disorder
Primary Outcome Measures
NameTimeMethod
mortality within 28 days after ICU admission28 days

percentage of patients who died within 28 days after admission

Secondary Outcome Measures
NameTimeMethod
ICU Stay6 months

mean of duration of ICU stay

Delirium6 months

percentage of patients with delirium

mortality within 90 days after ICU admission90 days

percentage of patients who died within 90 days after admission

duration on mechanical ventilation6 months

mean of duration of mechanical ventilation

Trial Locations

Locations (1)

Chu Reims

🇫🇷

Reims, France

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