BIS in Critically Ill Patients in ICU

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

About this trial

The Bispectral Index (BIS) is a monitor that converts brain electrical activity from EEG into a simple number from 0 to 100. A higher number means the patient is more awake, while a lower number means deeper sedation or reduced brain activity.

In general, 100 means fully awake, 80 suggests light to moderate sedation, 60 is commonly used as a target for general anesthesia with a low chance of awareness, 40 indicates deep anesthesia, 20 suggests marked brain suppression with burst suppression on EEG, and 0 indicates no detectable cortical electrical activity.

Although BIS was originally developed for use in the operating room, it has also been applied in the ICU to help guide sedation, avoid over- or under-sedation, and assess consciousness in patients who cannot be evaluated reliably using standard clinical scores. BIS has also been studied as a possible tool for predicting outcomes in comatose ICU patients, such as those after cardiac arrest, stroke, encephalitis, or traumatic brain injury. However, evidence is still limited for its use in predicting outcomes among ICU patients with any form of decreased consciousness. Therefore, this study was conducted to explore that role.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18years

RASS score ≤ -3 as case

RASS score 0 to -1 as control

Expected ICU length of stays ≥ 24hours

Disqualifiers

Contraindication for BIS monitoring (wound or infection at forehead)

No space for attach BIS monitoring at forehead

Patient with sedative drugs (Propofol, Midazolam, Dexmedetomidine)

Patient with acute stroke

Trial design

Design model

Parallel

Treatments tested in this trial

  • Processed EEG monitoring

    Other intervention

    Monitor processed EEG using BIS

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Decreased mental statusActive comparator 1 intervention
Group B: Normal mental statusPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

BIS value

Average BIS value during 24 hours period of monitoring

Time frame
24 hours following inclusion

Secondary outcomes

1

Length of stay in SICU

Total days of stay in SICU

Time frame
Up to 90 days following inclusion
2

Length of stay in hospital

Total days of stay in hospital

Time frame
Up to 90 days following inclusion
3

SICU discharge status

Status whether alive or decease

Time frame
Up to 90 days following inclusion
4

Hospital discharge status

Status whether alive or decease

Time frame
Up to 90 days following inclusion

Other outcomes

Sponsors and contacts

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