Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate the use of the Conox4 device in intensive care patients who require mechanical ventilation. The study addresses concerns that excessive sedation can prolong ventilation and increase risks such as low blood pressure, blood clots, and pneumonia. Current sedation practices rely on clinical signs, which may not always match patient needs accurately. The Conox4 system monitors brain activity through EEG to assess sedation and pain levels, potentially improving sedation management. Participants will be randomly assigned to one of two groups: one receiving sedation based on standard clinical scales like the Behavioral Pain Scale and Richmond Agitation-Sedation Scale, and the other guided by EEG-derived indexes (qCON/qNOX) from the Conox4 device. This approach aims to refine sedation and analgesia by providing objective brain activity measures. The study is single-blinded and compares these two sedation methods in patients expected to be mechanically ventilated for more than 48 hours. During the study, researchers will monitor ventilator-free days over 28 days as the main outcome. Secondary outcomes include the occurrence of delirium after extubation, length of ICU stay, and drug consumption until ICU discharge. Patients will be closely observed with clinical assessments and sedation monitoring throughout their ICU stay. Participation involves sedation management tailored by either standard care or EEG data, with ongoing evaluation of sedation effects and safety until ICU discharge or study end.

Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients