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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03835091
Acronym
BRASS-ICU
Enrollment
110
Registered
2019-02-08
Start date
2019-02-07
Completion date
2019-08-26
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brainstem Response

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.

Interventions

OTHERBRASS score

Brainstem response on neurologic examination

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mortality within 28 days after ICU admission28 dayspercentage of patients who died within 28 days after admission

Secondary

MeasureTime frameDescription
mortality within 90 days after ICU admission90 dayspercentage of patients who died within 90 days after admission
ICU Stay6 monthsmean of duration of ICU stay
Delirium6 monthspercentage of patients with delirium
duration on mechanical ventilation6 monthsmean of duration of mechanical ventilation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026