BIS in Critically Ill Patients in ICU
The Comparison of Bispectral Index Parameter Between Critically Ill Patients With and Without Decreased Mental Status and Its Association With Clinical Outcomes
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Annop Piriyapatsom, M.D.
- 電話番号：+66 2419 7990
- メール：annop.pir@mahidol.ac.th
研究場所
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Bangkok
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Bangkok Noi、Bangkok、タイ、10700
- Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
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コンタクト：
- Annop Piriyapatsom, M.D.
- 電話番号：+66 2419 7990
- メール：annop.pir@mahidol.ac.th
-
主任研究者：
- Annop Piriyapatsom, M.D.
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副調査官：
- Chatchawan Uacharuporn, M.D.
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副調査官：
- Tanuwong Viarasilpa, M.D.
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副調査官：
- Nattachai Hemtanon, M.D.
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副調査官：
- Suchanun Lao-amornphunkul, M.D.
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副調査官：
- Natthicha Papbamnarn, M.D.
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副調査官：
- Chayanan Thanakiattiwibun
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Decreased mental status
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Monitor processed EEG using BIS
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プラセボコンパレーター：Normal mental status
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Monitor processed EEG using BIS
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
BIS value
時間枠：24 hours following inclusion
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Average BIS value during 24 hours period of monitoring
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24 hours following inclusion
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Length of stay in SICU
時間枠：Up to 90 days following inclusion
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Total days of stay in SICU
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Up to 90 days following inclusion
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|
Length of stay in hospital
時間枠：Up to 90 days following inclusion
|
Total days of stay in hospital
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Up to 90 days following inclusion
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SICU discharge status
時間枠：Up to 90 days following inclusion
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Status whether alive or decease
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Up to 90 days following inclusion
|
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Hospital discharge status
時間枠：Up to 90 days following inclusion
|
Status whether alive or decease
|
Up to 90 days following inclusion
|
|
Status at 30 days
時間枠：Up to 30 days following inclusion
|
Status whether alive or decease
|
Up to 30 days following inclusion
|
|
Status at 90 days
時間枠：Up to 90 days following inclusion
|
Status whether alive or decease
|
Up to 90 days following inclusion
|
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ICU Memory
時間枠：Up to 90 days following inclusion
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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). |
Up to 90 days following inclusion
|
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Post-traumatic Stress Disorder
時間枠：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.
|
Up to 90 days following inclusion
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
- Selig C, Riegger C, Dirks B, Pawlik M, Seyfried T, Klingler W. Bispectral index (BIS) and suppression ratio (SR) as an early predictor of unfavourable neurological outcome after cardiac arrest. Resuscitation. 2014 Feb;85(2):221-6. doi: 10.1016/j.resuscitation.2013.11.008. Epub 2013 Nov 25.
- Eertmans W, Genbrugge C, Vander Laenen M, Boer W, Mesotten D, Dens J, Jans F, De Deyne C. The prognostic value of bispectral index and suppression ratio monitoring after out-of-hospital cardiac arrest: a prospective observational study. Ann Intensive Care. 2018 Mar 2;8(1):34. doi: 10.1186/s13613-018-0380-z.
- Perez-Otal B, Aragon-Benedi C, Pascual-Bellosta A, Ortega-Lucea S, Martinez-Ubieto J, Ramirez-Rodriguez JM; Research Group in Anaesthesia, Resuscitation, and Perioperative Medicine of Institute for Health Research Aragon (ISS Aragon). Neuromonitoring depth of anesthesia and its association with postoperative delirium. Sci Rep. 2022 Jul 26;12(1):12703. doi: 10.1038/s41598-022-16466-y.
- Misis M, Raxach JG, Molto HP, Vega SM, Rico PS. Bispectral index monitoring for early detection of brain death. Transplant Proc. 2008 Jun;40(5):1279-81. doi: 10.1016/j.transproceed.2008.03.145.
- Vivien B, Paqueron X, Le Cosquer P, Langeron O, Coriat P, Riou B. Detection of brain death onset using the bispectral index in severely comatose patients. Intensive Care Med. 2002 Apr;28(4):419-25. doi: 10.1007/s00134-002-1219-4. Epub 2002 Mar 19.
- Dou L, Gao HM, Lu L, Chang WX. Bispectral index in predicting the prognosis of patients with coma in intensive care unit. World J Emerg Med. 2014;5(1):53-6. doi: 10.5847/wjem.j.issn.1920-8642.2014.01.009.
- Arbas-Redondo E, Rosillo-Rodriguez SO, Merino-Argos C, Marco-Clement I, Rodriguez-Sotelo L, Martinez-Marin LA, Martin-Polo L, Velez-Salas A, Caro-Codon J, Garcia-Arribas D, Armada-Romero E, Lopez-De-Sa E. Bispectral index and suppression ratio after cardiac arrest: are they useful as bedside tools for rational treatment escalation plans? Rev Esp Cardiol (Engl Ed). 2022 Dec;75(12):992-1000. doi: 10.1016/j.rec.2022.03.004. Epub 2022 May 12. English, Spanish.
- Heavner MS, Gorman EF, Linn DD, Yeung SYA, Miano TA. Systematic review and meta-analysis of the correlation between bispectral index (BIS) and clinical sedation scales: Toward defining the role of BIS in critically ill patients. Pharmacotherapy. 2022 Aug;42(8):667-676. doi: 10.1002/phar.2712. Epub 2022 Jun 30.
- Huespe I, Giunta D, Acosta K, Avila D, Prado E, Sanghavi D, Bisso IC, Giannasi S, Carini FC. Comparing Bispectral Index Monitoring vs Clinical Assessment for Deep Sedation in the ICU: Effects on Delirium Reduction and Sedative Drug Doses-A Randomized Trial. Chest. 2024 Oct;166(4):733-742. doi: 10.1016/j.chest.2024.05.031. Epub 2024 Jun 18.
- Tasaka CL, Duby JJ, Pandya K, Wilson MD, A Hardin K. Inadequate Sedation During Therapeutic Paralysis: Use of Bispectral Index in Critically Ill Patients. Drugs Real World Outcomes. 2016 May 28;3(2):201-208. doi: 10.1007/s40801-016-0076-3. eCollection 2016 Jun.
- Manning J, Chiasson M. Does Bispectral Index Monitoring Belong in the Intensive Care Unit Setting?: A Narrative Review of Evidence. Dimens Crit Care Nurs. 2025 Sep-Oct 01;44(5):231-238. doi: 10.1097/DCC.0000000000000713.
- Yang Y, Song C, Song C, Li C. Comparison of Bispectral Index-Guided Individualized Anesthesia with Standard General Anesthesia on Inadequate Emergence and Postoperative Delirium in Elderly Patients Undergoing Esophagectomy: A Retrospective Study at a Single Center. Med Sci Monit. 2020 Oct 1;26:e925314. doi: 10.12659/MSM.925314.
- Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
- Riddell JR, Fernandes BM, Jadav RH, Wise MP. Monitoring Sedation Depth in Critical Illness, State-of-the-Art Practice. Crit Care Clin. 2025 Oct;41(4):707-720. doi: 10.1016/j.ccc.2025.06.001. Epub 2025 Jul 14.
- Gilbert TT, Wagner MR, Halukurike V, Paz HL, Garland A. Use of bispectral electroencephalogram monitoring to assess neurologic status in unsedated, critically ill patients. Crit Care Med. 2001 Oct;29(10):1996-2000. doi: 10.1097/00003246-200110000-00024.
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研究開始 (推定)
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研究の完了 (推定)
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最終確認日
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キーワード
その他の研究ID番号
- 037/2569(IRB1)
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