Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 10:56 PM
Ignite Modification Date: 2025-12-24 @ 10:56 PM
NCT ID: NCT00538369
Brief Summary: When a physiologic tool to measure the patient's hypnotic state is added to current practice tools is there a decrease in the amount of drug the patient receives.
Detailed Description: The purposes of this study were to examine the effect of combining a physiologic measure of consciousness (BIS) with observational assessment of sedation (Ramsay) on infused sedation drug volumes, undersedation events, and the recovery time to arouse from sedation, in a group of neurocritically ill patients. During a 12-hour data collection period, patients received sedation assessment and management with either the current standard of care (sedation assessment with the Ramsay scale), or the standard of care plus the addition of physiologic data from BIS monitoring. Planned research questions explored how BIS monitoring impacts short-term sedation-related outcomes. Research Questions * Is there less sedation drug use for patients when nurses monitor sedation with BIS augmentation of Ramsay than when nurses monitor patients with Ramsay alone? * Is sedation assessment augmented by BIS use associated with a decreased time to wake-up (recovery time) when nurses are instructed to interrupt sedation and obtain a neurologic examination, compared to use of Ramsay alone? * Are there differences in the number of events associated with undersedation (e.g., self-extubation) for patients assigned to BIS augmentation compared to patients assigned to Ramsay alone?
Study: NCT00538369
Study Brief:
Protocol Section: NCT00538369