Category
»
Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
»
2024
INTERVENTION: This is a prospective, randomized, unblinded clinical trial. Participants will be randomly divided into two groups: a control group, which will not receive BIS monitoring, and an intervention group, which will have BIS monitoring. Randomization was carried out to maintain a similar number of patients in each group throughout the recruitment period, using the block randomization method, thus, it is intended to evaluate 60 patients, thirty in the control group and thirty in the intervention group (which could be vary by more or less two patients). Both groups will be treated according to the protocols established in the Intensive Care Unit (ICU), the difference will be BIS monitoring in the intervention group. Patients under mechanical ventilation and using analgosedation will be analyzed to verify whether the dose of sedatives and analgesics is adequate according to the parameters established by AMIB. A calculator developed in Excel will be used to evaluate the doses of sedoanalgesics. If the doses do not comply with the protocol, these patients must be included in the study after checking the exclusion criteria. In the control group, sedation assessment will be carried out according to the routine already established in the ICU, from the beginning of sedation until extubation, discharge or death of these patients. Demographic data will be collected, such as gender, age, weight, comorbidities, ICU admission diagnosis, as well as information on the duration of mechanical ventilation and length of stay in the ICU. The sedative and analgesic medications prescribed, their doses, flow rates, consumption, RASS scale values recorded by physiotherapists and doctors and the patients' final outcome will also be recorded. In the intervention group, BIS monitoring will be carri CONDITION: Conscious Sedation E07.858.195 PRIMARY OUTCOME: Assess adverse effects related to sedation Assess the death rate Assess the discharge rate Compare the duration of mechanical ventilation and the length of stay in the Intensive Care Unit (ICU) in the two study groups Evaluating the effectiveness of consciousness monitoring using the Bispectral Index compared to subjective clinical monitoring SECONDARY OUTCOME: Analyze the consumption of sedatives and analgesics Analyze the economic impact Assess wake‐up time Evaluate the outcome of pharmaceutical interventions regarding sedoanalgesia based on ; monitoring the Bispectral Inde X(BIS) INCLUSION CRITERIA: Age over 18 years old; female and male sex; mechanical ventilation via endotracheal tube; using continuous intravenous sedation at doses above those recommended
Epistemonikos ID: 647daf4cc6b1ac44fe94fd1fddc3cac2e4c2c63e
First added on: Aug 28, 2024