BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation

Delirium Clinical Trial

Official title:

Effect of Bispectral Index (BIS)-Guided Sedation on Delirium and Sedative Drug Requirements in Critically Ill Patients Under Deep Sedation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03840577
• Other study ID #: 3880
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2023
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate the effectiveness of sedation guided by the bispectral index (BIS) in reducing the incidence of delirium and the doses of sedative drugs used in critical patients who require deep sedation. The main questions this study aims to answer are: - Does sedation guided by BIS lead to higher delirium and coma-free days compared to clinical monitoring? - Does sedation guided by BIS result in reduced doses of sedative drugs compared to clinical monitoring? Participants in this study will be randomly assigned to one of two groups: Clinical Monitoring Group: Participants in this group will receive sedation based on clinical scales. These participants will also be fitted with a BIS sensor, but the sensor will be covered. Sedation Guided by BIS Group: Participants in this group will receive sedation guided by the bispectral index. The study will be conducted as a prospective, controlled, blind intervention trial with random distribution and intention to treat. The primary outcomes to be evaluated include: - Delirium and coma-free days after the end of deep sedation using the Confusion Assessment Method for the ICU (CAM-ICU) scale. - Total dose of sedative drugs administered. - BIS values Researchers will compare the two groups to determine if sedation guided by BIS is associated with a higher number of delirium and coma-free days, reduced sedative drug doses, and higher values of BIS compared to clinical monitoring.

Description:

A Phase 4, randomized (1:1), controlled, double-blind, unicenter clinical trial aims to assess the effectiveness of sedation guided by the Bispectral Index (BIS) compared to sedation guided by clinical scales in critically ill patients under deep sedation. The primary objective is to investigate whether BIS-guided sedation can reduce the incidence of delirium and decrease the doses of sedative drugs administered.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: January 1, 2024
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years.
• Under mechanical ventilation in the intensive care unit
• Indication of deep sedation (RASS objective -4, -5)
• Admission to the ICU or indication of deep sedation up to 8 hours prior to randomization.

Exclusion Criteria:

• Patients with end-of-life care.
• Family refusal to participate in the study.
• Impossibility to place the BIS sensor (burns, extensive lesions on the forehead, prone position, etc.).
• Patients with intracranial hypertension or convulsive status, in whom sedation has the objective of suppressing electroencephalographic waves.
• Patients who, following a decrease in sedation, have a coma, vegetative state or a state of minimal consciousness.

Related Conditions & MeSH terms

• Delirium
• Sedative Overdose

Intervention

Device:
• Monitorization of sedation by Bispectral Index
The sedative dose administered through a continuous infusion pump will be adjusted based on the BIS value to maintain a target range of 40 to 60. If the BIS value is below the target range, the dose will be increased, and if it exceeds the range, the dose will be decreased, aiming to keep the BIS within the desired range.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Capital Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (6)

Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299. — View Citation

Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012. — View Citation

MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018 Sep;129(3):417-427. doi: 10.1097/ALN.0000000000002323. — View Citation

Salluh JI, Soares M, Teles JM, Ceraso D, Raimondi N, Nava VS, Blasquez P, Ugarte S, Ibanez-Guzman C, Centeno JV, Laca M, Grecco G, Jimenez E, Arias-Rivera S, Duenas C, Rocha MG; Delirium Epidemiology in Critical Care Study Group. Delirium epidemiology in critical care (DECCA): an international study. Crit Care. 2010;14(6):R210. doi: 10.1186/cc9333. Epub 2010 Nov 23. — View Citation

Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138. — View Citation

Shetty RM, Bellini A, Wijayatilake DS, Hamilton MA, Jain R, Karanth S, Namachivayam A. BIS monitoring versus clinical assessment for sedation in mechanically ventilated adults in the intensive care unit and its impact on clinical outcomes and resource utilization. Cochrane Database Syst Rev. 2018 Feb 21;2(2):CD011240. doi: 10.1002/14651858.CD011240.pub2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare mortality at 60 days after randomization	To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on mortality at 60 days after randomization	Until 60 days after randomization
Primary	Compare delirium and coma free days until 14 days after end of deep sedation	To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3.	Up to 14 days post end of deep sedation
Primary	Compare the doses of sedative drugs received	To compare the total doses of Propofol, Midazolam, and Remifentanil (calculated in mg/kg) received during the period of deep sedation	From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
Primary	Compare values of BIS	To compare the values of Bispectral Index (BIS) in patients receiving sedation guided by the Bispectral Index (BIS) versus sedation guided by clinical scales. This outcome will assess the BIS values recorded during the period of deep sedation and compare them between the two groups	From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
Secondary	Time with values of BIS less than 40	To compare the number of hours that patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales had registered Bispectral Index (BIS) values below 40 during the period of deep sedation. The duration of time with BIS values below 40 will be recorded for each patient.	From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
Secondary	Compare days alive and free of the ICU	To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the ICU	From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 120 days
Secondary	Compare days alive and free of the hospital	To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the hospital	From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days
Secondary	Compare days alive and free of mechanical ventilation through Study Day 30	To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 30	From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 30 days
Secondary	Compare days alive and free of mechanical ventilation through Study Day 60	To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 60	From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 60 days
Secondary	Compare delirium and coma free days until 14 days after end of deep sedation in patients who had more than 24 hours of deep sedation	To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3, in patients who had more than 24 hours of deep sedation	Up to 14 days post end of deep sedation