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NCT Number: NCT07583732

BIS in Critically Ill Patients in ICU

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location contact

Annop Piriyapatsom, M.D.

CONTACT

[email protected]

+66 2419 7990

Annop Piriyapatsom, M.D.

PRINCIPAL_INVESTIGATOR

Chatchawan Uacharuporn, M.D.

SUB_INVESTIGATOR

Chayanan Thanakiattiwibun

SUB_INVESTIGATOR

Nattachai Hemtanon, M.D.

SUB_INVESTIGATOR

Natthicha Papbamnarn, M.D.

SUB_INVESTIGATOR

Suchanun Lao-amornphunkul, M.D.

SUB_INVESTIGATOR

Tanuwong Viarasilpa, M.D.

SUB_INVESTIGATOR

About this study

The Bispectral Index is the output of a multi-stage process that transforms the brain's electrical activity into a simplified metric. This process begins with non-invasive data acquisition and proceeds through advanced computational analysis to derive the final index.

The BIS monitor translates the EEG data into a number on a scale from 0 to 100. This index is designed to provide a direct measure of a patient's level of consciousness and response to sedation, with specific numeric ranges corresponding to general clinical states.

The generally accepted clinical correlations for the BIS scale are as follows:

  • 100: This value indicates a patient who is fully awake and alert, corresponding to a state of responsiveness to a normal voice.
  • 80: This range is typically associated with light to moderate sedation or anxiolysis. A patient in this range may respond to loud verbal commands or mild physical stimulation, such as prodding or shaking.
  • 60: This value is a critical threshold often targeted for general anesthesia. It represents a low probability of explicit recall and unresponsiveness to verbal stimuli. A BIS value of less than 60 has a high sensitivity for identifying a state of drug-induced unconsciousness, making it a key target in the operating room to prevent awareness.
  • 40: This range signifies a deep hypnotic state, with a greater degree of cortical suppression than is typically required for general anesthesia.
  • 20: A BIS value in this range indicates the presence of burst suppression on the EEG. This pattern, characterized by periods of electrical activity (bursts) alternating with periods of isoelectricity (suppression), reflects a very deep level of brain suppression seen with high doses of anesthetic agents or in conditions like barbiturate coma or severe anoxic brain injury.
  • 0: A BIS value of 0 represents a flatline or isoelectric EEG, indicating the absence of detectable cortical electrical activity.

BIS monitoring was adapted from the operating room to the ICU to help manage the difficult task of sedating critically ill patients.

Its main goals in the ICU are to:

  • Prevent the risks of over- or under-sedation.
  • Provide an objective number to guide medication dosage.
  • Assess consciousness in patients who can't be evaluated by normal methods. BIS monitoring is being used more frequently to assess the depth of sedation in ICU patients, as opposed to relying solely on clinical scoring systems.

The Bispectral Index (BIS) has been used to predict clinical outcomes in ICU patients with coma from various causes, including post-cardiac arrest, cerebrovascular disease, viral encephalitis, and traumatic brain injury. However, there is limited research on using BIS to predict outcomes for patients with any decreased level of consciousness in the ICU. Therefore, this study was initiated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18years
  • RASS score ≤ -3 as case
  • RASS score 0 to -1 as control
  • Expected ICU length of stays ≥ 24hours

Exclusion criteria

  • 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
  • Patient was already on EEG monitoring
  • Denied by patients or patient's surrogates

Treatment and study plan

Processed EEG monitoring

Other

Monitor processed EEG using BIS

Primary outcomes

  1. BIS value

    Time frame: 24 hours following inclusion

    Average BIS value during 24 hours period of monitoring

Secondary outcomes

  1. Length of stay in SICU

    Time frame: Up to 90 days following inclusion

    Total days of stay in SICU

  2. Length of stay in hospital

    Time frame: Up to 90 days following inclusion

    Total days of stay in hospital

  3. SICU discharge status

    Time frame: Up to 90 days following inclusion

    Status whether alive or decease

  4. Hospital discharge status

    Time frame: Up to 90 days following inclusion

    Status whether alive or decease

  5. Status at 30 days

    Time frame: Up to 30 days following inclusion

    Status whether alive or decease

  6. Status at 90 days

    Time frame: Up to 90 days following inclusion

    Status whether alive or decease

  7. ICU Memory

    Time frame: Up to 90 days following inclusion

    ICU Memory Tool:

    Three domains: ICU environment (family, alarms, tubes), feelings (pain, agitation, confusion), delusions (dreams, hallucinations).

    A self-rated format for frequency, ranging from 0 to 2 (never, sometimes, and often).

  8. Post-traumatic Stress Disorder

    Time frame: Up to 90 days following inclusion

    Post-traumatic Stress Disorder (PTSD) assessed by Impact of Event scale (IES)-6 which comprised 6 questions, each scored from 0 to 4 (Not at all, a little bit, moderately, quite a bit, extremely). Mean IES-6 score ≥ 1.75 considers positive screening for PTSD.

Study contacts

Contact information is provided by the study sponsor or research team.

Annop Piriyapatsom, M.D.

CONTACT

[email protected]

+66 2419 7990

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

The Comparison of Bispectral Index Parameter Between Critically Ill Patients With and Without Decreased Mental Status and Its Association With Clinical Outcomes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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