BIS in Critically Ill Patients in ICU

NCT07583732 | Not Yet Recruiting

• 1 other identifier: 037/2569(IRB1)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill Patients

Keywords

BIS; processed EEG; ICU patient; Sedation; Neuromonitoring

Outcome Measures

Primary Outcomes (1)

• BIS value

  Average BIS value during 24 hours period of monitoring

  24 hours following inclusion

Secondary Outcomes (8)

• Length of stay in SICU

  Up to 90 days following inclusion

• Length of stay in hospital

  Up to 90 days following inclusion

• SICU discharge status

  Up to 90 days following inclusion

• Hospital discharge status

  Up to 90 days following inclusion

• Status at 30 days

  Up to 30 days following inclusion

Study Arms (2)

Decreased mental status

ACTIVE COMPARATOR

Decreased mental status

Other: Processed EEG monitoring

Normal mental status

PLACEBO COMPARATOR

Normal mental status

Other: Processed EEG monitoring

Interventions

Processed EEG monitoring OTHER

Monitor processed EEG using BIS

Decreased mental status; Normal mental status

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (16)

• 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.

  PMID: 18589087 RESULT

• 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.

  PMID: 11967595 RESULT

• 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.

  PMID: 25215148 RESULT

• 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.

  PMID: 35570124 RESULT

• 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.

  PMID: 35707961 RESULT

• 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.

  PMID: 38901489 RESULT

• 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.

  PMID: 27398299 RESULT

• 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.

  PMID: 40719578 RESULT

• 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.

  PMID: 29500559 RESULT

• 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.

  PMID: 24287327 RESULT

• 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.

  PMID: 35882875 RESULT

• 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.

  PMID: 33001868 RESULT

• 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.

  PMID: 18337600 RESULT

• 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.

  PMID: 15172773 RESULT

• 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.

  PMID: 41101833 RESULT

• 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.

  PMID: 11588470 RESULT

Central Study Contacts

Annop Piriyapatsom, M.D.

CONTACT

+66 2419 7990; annop.pir@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 13, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD and supporting information will be available once the study has already published and last for 1 year.
• Access Criteria: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Locations

TH (1)