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

NCT ID: NCT03835091

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-07
• Study Completion Date: 2019-08-26

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.

Conditions

Brainstem Response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient with mechanical ventilation and sedation

All patient hospitalized in intensive care under sedation and mechanical ventilation without neurologic disorder

BRASS score

Intervention Type: OTHER

Brainstem response on neurologic examination

Interventions

BRASS score

Brainstem response on neurologic examination

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Reims

Reims, , France

Countries

France

References

Legros V, Mourvillier B, Floch T, Candelier Q, Rosman J, Lafont B, Farkas JC, Bard M, Kanagaratnam L, Mateu P. Use of BRASS in sedated critically-ill patients as a predictable mortality factor: BRASS-ICU. Neurol Res. 2021 Apr;43(4):283-290. doi: 10.1080/01616412.2020.1849901. Epub 2020 Nov 19.

Reference Type: DERIVED

PMID: 33208055 (View on PubMed)

Other Identifiers

PO18167

Identifier Type: -

Identifier Source: org_study_id