BIS in Critically Ill Patients in ICU
6. Mai 2026 aktualisiert von: Mahidol University
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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Annop Piriyapatsom, M.D.
- Telefonnummer: +66 2419 7990
- E-Mail: annop.pir@mahidol.ac.th
Studienorte
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Bangkok
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Bangkok Noi, Bangkok, Thailand, 10700
- Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
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Kontakt:
- Annop Piriyapatsom, M.D.
- Telefonnummer: +66 2419 7990
- E-Mail: annop.pir@mahidol.ac.th
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Hauptermittler:
- Annop Piriyapatsom, M.D.
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Unterermittler:
- Chatchawan Uacharuporn, M.D.
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Unterermittler:
- Tanuwong Viarasilpa, M.D.
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Unterermittler:
- Nattachai Hemtanon, M.D.
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Unterermittler:
- Suchanun Lao-amornphunkul, M.D.
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Unterermittler:
- Natthicha Papbamnarn, M.D.
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Unterermittler:
- Chayanan Thanakiattiwibun
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Decreased mental status
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Monitor processed EEG using BIS
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Placebo-Komparator: Normal mental status
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Monitor processed EEG using BIS
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
BIS value
Zeitfenster: 24 hours following inclusion
|
Average BIS value during 24 hours period of monitoring
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24 hours following inclusion
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Length of stay in SICU
Zeitfenster: Up to 90 days following inclusion
|
Total days of stay in SICU
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Up to 90 days following inclusion
|
|
Length of stay in hospital
Zeitfenster: Up to 90 days following inclusion
|
Total days of stay in hospital
|
Up to 90 days following inclusion
|
|
SICU discharge status
Zeitfenster: Up to 90 days following inclusion
|
Status whether alive or decease
|
Up to 90 days following inclusion
|
|
Hospital discharge status
Zeitfenster: Up to 90 days following inclusion
|
Status whether alive or decease
|
Up to 90 days following inclusion
|
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Status at 30 days
Zeitfenster: Up to 30 days following inclusion
|
Status whether alive or decease
|
Up to 30 days following inclusion
|
|
Status at 90 days
Zeitfenster: Up to 90 days following inclusion
|
Status whether alive or decease
|
Up to 90 days following inclusion
|
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ICU Memory
Zeitfenster: 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). |
Up to 90 days following inclusion
|
|
Post-traumatic Stress Disorder
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn (Geschätzt)
15. Mai 2026
Primärer Abschluss (Geschätzt)
31. Januar 2027
Studienabschluss (Geschätzt)
31. März 2027
Studienanmeldedaten
Zuerst eingereicht
3. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Mai 2026
Zuerst gepostet (Tatsächlich)
13. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 037/2569(IRB1)
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Beschreibung des IPD-Plans
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD-Sharing-Zeitrahmen
IPD and supporting information will be available once the study has already published and last for 1 year.
IPD-Sharing-Zugriffskriterien
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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- STUDIENPROTOKOLL
- SAFT
- CSR
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Nein
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