The University of Queensland, in collaboration with Medtronic, has announced an upcoming clinical trial to evaluate whether displaying density spectral array (DSA) alongside the Bispectral Index (BIS) provides superior monitoring during general anesthesia. This study aims to enhance patient safety by improving the depth-of-anesthesia metrics used during surgical procedures.
Publication Date: November 18, 2025
What changed?
The trial, listed on ClinicalTrials.gov, proposes the integration of DSA—a type of processed EEG data—with the widely used BIS index. BIS is already a standard for monitoring brain activity to ensure patients remain unconscious during general anesthesia. This additional use of DSA may provide real-time, detailed insights into brain function, potentially reducing the risk of intraoperative awareness.
Currently, the trial is marked as “not yet recruiting.” Once initiated, its results could pave the way for new depth-of-anesthesia monitoring guidelines.
What does the study investigate?
Study Name: Is Density Spectral Array Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone?
Sponsors: The University of Queensland and Medtronic
Condition Studied: Awareness during general anesthesia
Intervention: A device-based depth-of-anesthesia monitoring system using processed EEG data such as DSA and BIS
The primary goal of this study is to determine if displaying DSA data alongside BIS improves clinical outcomes or provides anesthesiologists with more actionable insights during surgery.
According to the trial description, the study seeks to gather data to assess whether this combined approach could optimize patient safety and anesthesia dosing during medical procedures.
Who is impacted?
The findings of this trial will be relevant to several stakeholders, including:
- Healthcare providers: Particularly anesthesiologists and surgical teams aiming to improve intraoperative monitoring and patient outcomes.
- Medical device manufacturers: Organizations creating EEG and BIS-based devices will find this data useful for product innovation and regulatory strategy.
- Clinical and regulatory professionals: This trial may influence guidance on anesthetic monitoring practices globally.
This research could directly benefit patients by advancing methods to reduce cases of anesthesia awareness—a rare but critical event affecting surgical procedures.
FAQ
- What is the density spectral array (DSA)?
DSA is a graphical representation of EEG frequencies that provides detailed real-time insights into brain activity. - How is the Bispectral Index (BIS) used?
BIS is a processed single-number metric derived from EEG data, widely used to assess the depth of anesthesia in patients undergoing surgery. - Why combine DSA with BIS?
Combining these methods could provide a more comprehensive view of brain activity, improving decision-making and reducing adverse events such as anesthesia awareness. - When does the study start?
The clinical trial is not yet recruiting, and further updates will likely provide exact timelines.
Conclusion
The University of Queensland and Medtronic are set to investigate the potential benefits of combining DSA with BIS for anesthesia monitoring. If successful, this development could lead to enhanced safety standards. Stakeholders in anesthesia devices and monitoring are encouraged to follow this trial for future developments, as it could significantly influence market practices and regulatory policies.
Disclaimer
This article is intended for clinical, regulatory, and quality professionals. It is not legal or medical advice. Always consult relevant guidelines and experts.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07232160?term=medical+device