BIS in ICU Interventional Study

Официальное название

Effect of BIS-Guided Sedation on Clinical Outcomes in Postoperative Cardiac Surgery ICU Patients: A Prospective, Randomized Controlled Trial

Обзор

This study will test whether using a Bispectral Index (BIS) monitor to guide sedation can reduce the amount of sedative medication given to adults in the intensive care unit (ICU) after cardiac surgery. BIS is a non-invasive, EEG-based monitor that shows a number from 0-100 to reflect level of consciousness. Researchers will compare BIS-guided sedation to standard sedation guided by clinical scales (such as the Richmond Agitation-Sedation Scale, RASS). About 144 participants will be randomly assigned (1:1) to one of two groups at two hospitals in Austria (Medical University of Graz and Klinikum Wels-Grieskirchen). In the BIS group, clinicians will use BIS values and standard care to titrate sedation and will aim to avoid sustained BIS values below 50. In the control group, sedation will follow standard practices using clinical scales; BIS will be recorded but hidden from caregivers. The trial is open-label for treating staff; outcome assessors and data analysts will be blinded. Participants will be in the study during their ICU sedation and mechanical ventilation period (typically more than 6 hours), with follow-up through ICU and hospital discharge. The primary outcome is the time-averaged dose of propofol (mg/kg/h) given during continuous ICU sedation until weaning (up to 72 hours). Secondary outcomes include duration of ventilation and sedation, depth of sedation measures, sedative and catecholamine doses, pulmonary infections (including ventilator-associated pneumonia), ICU and hospital length of stay, delirium, and in-hospital mortality. Risks are minimal and may include mild skin irritation from forehead electrodes. Possible benefits include improved sedation management; benefits are not guaranteed. Taking part is voluntary.

Вмешательства

• Другое Device-guided sedation
  in addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation
• Другое standard sedation practice
  sedation due to standard clinical practice, using sedation scores such as RASS-Score

Первичные конечные точки

• time-averaged Propofol dose during continuous ICU sedation [Срок оценки: immediately after discontinuation of propofol]

Вторичные конечные точки (10)

• Duration of invasive mechanical ventilation [Срок оценки: immediately after extubation]
• Duration of continuous sedation [Срок оценки: immediately after extubation]
• Incidence of pulmonary infections [Срок оценки: at ICU discharge]
• Proportion of time spent in deep sedation [Срок оценки: immediately after discontinuation of Propofol]
• BIS values over time [Срок оценки: immediately after discontinuation of Propofol]
• Length of ICU stay [Срок оценки: at ICU discharge]
• Total hospital length of stay [Срок оценки: at hospital discharge]
• In-hospital mortality [Срок оценки: at ICU discharge]
• Incidence of ICU delirium [Срок оценки: immediately after extubation]
• Time-averaged catecholamine dose administered (in mcg/kg/min) during continuous sedation [Срок оценки: immediately after discontinuation of Propofol]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Undergoing cardiac surgery with subsequent admission to the intensive care unit (e.g., valve surgery, coronary artery bypass grafting, aortic surgery)
• Planned or expected duration of invasive mechanical ventilation > 6 hours postoperatively
• Requirement for continuous sedation during ICU stay

Критерии исключения

• Pre-existing neurological disorders affecting consciousness or sedation assessment (e.g., severe dementia, epileptic encephalopathy).
• Acute neurological events in the perioperative period (e.g., stroke, intracranial hemorrhage).
• Severe hepatic dysfunction (Child-Pugh Class C).
• Participation in another interventional study potentially affecting sedation or cognitive outcomes.
• Pregnancy or lactation.
• Do-not-intubate (DNI)/Do-not-resuscitate (DNR) orders or documented limitation of therapy.
• Patients in whom short-term survival is deemed unlikely due to the clinical course.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07350122 · 1579

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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