Clinical trial NCT03840577: BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation
Official title: Effect of Bispectral Index (BIS)-Guided Sedation on Delirium and Sedative Drug Requirements in Critically Ill Patients Under Deep Sedation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Delirium
Sedative Overdose
Keywords: Deep Sedation
Bispectral index
Critical care patients
Delirium
Sedatives
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned according to the randomization to clinical monitoring groups or Bispectral Index (BIS) monitoring group. The ranzomization will be stratified randomization by neuromuscular bloquers.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare delirium and coma free days until 14 days after end of deep sedation
timeFrame: Up to 14 days post end of deep sedation
measure: Compare the doses of sedative drugs received
timeFrame: 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
measure: Compare values of BIS
timeFrame: 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 outcomes:
measure: Time with values of BIS less than 40
timeFrame: 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
measure: Compare days alive and free of the ICU
timeFrame: 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
measure: Compare days alive and free of the hospital
timeFrame: 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
measure: Compare days alive and free of mechanical ventilation through Study Day 30
timeFrame: 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
measure: Compare days alive and free of mechanical ventilation through Study Day 60
timeFrame: 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
measure: 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
timeFrame: Up to 14 days post end of deep sedation
Other outcomes:
measure: Compare mortality at 60 days after randomization
timeFrame: Until 60 days after randomization
Locations:
city: Capital Federal
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Sergio Giannasi, MD
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Federico Carini, MD
role: STUDY_DIRECTOR
affiliation: Hospital Italiano de Buenos Aires
name: Ivan A. Huespe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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.