BIS in Critically Ill Patients in ICU
6. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Annop Piriyapatsom, M.D.
- Telefonnummer: +66 2419 7990
- E-post: annop.pir@mahidol.ac.th
Studiesteder
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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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Ta kontakt med:
- Annop Piriyapatsom, M.D.
- Telefonnummer: +66 2419 7990
- E-post: annop.pir@mahidol.ac.th
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Hovedetterforsker:
- Annop Piriyapatsom, M.D.
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Underetterforsker:
- Chatchawan Uacharuporn, M.D.
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Underetterforsker:
- Tanuwong Viarasilpa, M.D.
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Underetterforsker:
- Nattachai Hemtanon, M.D.
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Underetterforsker:
- Suchanun Lao-amornphunkul, M.D.
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Underetterforsker:
- Natthicha Papbamnarn, M.D.
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Underetterforsker:
- Chayanan Thanakiattiwibun
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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BIS value
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Length of stay in SICU
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 90 days following inclusion
|
Status whether alive or decease
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Up to 90 days following inclusion
|
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Hospital discharge status
Tidsramme: Up to 90 days following inclusion
|
Status whether alive or decease
|
Up to 90 days following inclusion
|
|
Status at 30 days
Tidsramme: Up to 30 days following inclusion
|
Status whether alive or decease
|
Up to 30 days following inclusion
|
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Status at 90 days
Tidsramme: 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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ICU Memory
Tidsramme: 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
Tidsramme: 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.
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Up to 90 days following inclusion
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. mai 2026
Primær fullføring (Antatt)
31. januar 2027
Studiet fullført (Antatt)
31. mars 2027
Datoer for studieregistrering
Først innsendt
3. mai 2026
Først innsendt som oppfylte QC-kriteriene
6. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 037/2569(IRB1)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD-delingstidsramme
IPD and supporting information will be available once the study has already published and last for 1 year.
Tilgangskriterier for IPD-deling
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .