New York, New York 10029

  • Information Systems

Purpose:

The objective of this study is to use a decision-support system combined with an electronic anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) < 75 mmHg, and Bispectral Index (BIS) < 45) and generate alerts suggesting hemodynamic support. Specifically, the project will test the hypothesis that providing Double Low alerts reduces 90-day mortality. Secondary outcomes will be the fraction of alerts that generate early clinician responses, subsequent changes in MAP and hospital length of stay.


Study summary:

Data that is routinely collected as part of standard of care intraoperative monitoring including blood pressure, amount of anesthetic administered and a form of processes electroencephalogram called the bispectral index, which is a measure of depth of anesthesia all enter in an electronic record keeper. This project monitors for a combination of a blood pressure below mean of 75mmHg and a BIS of 45. When this is detected, half of the anesthesiologists caring for patients receive a text message on the computer screen and their pagers indicating that a double low situation exists and that they should consider intervening. The other half of practitioners are not provided with the additional messages, although all of the same information is available in the operating room (OR). Most patients undergoing general non-cardiac anesthesia at Mount Sinai are eligible. Documentation of consent was waived. All patients are informed of the ongoing project upon admission and are given a variety of methods of opting out of the project. The analysis seeks to determine if the messages were effective at influencing clinician behavior and whether that change would make a difference in either length of stay or 90 day mortality.


Criteria:

Inclusion Criteria: - All patients presenting for general anesthesia and have BIS monitors Exclusion Criteria: - patients who opt out of the study


NCT ID:

NCT01545596


Primary Contact:

Principal Investigator
David Reich, MD
Mount Sinai School of Medicine

Dionne Bobb
Phone: 212-241-7749
Email: dionne.bobb@mssm.edu


Backup Contact:

N/A


Location Contact:

New York, New York 10029
United States

Dionne Bobb
Phone: 212-241-7749
Email: dionne.bobb@mssm.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 07, 2022

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.