Clinical trial NCT01545596: Will a Real Time Advisory for Double Low State Change Clinical Behavior and Impact Outcomes
Official title: A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Double and Triple Low Combination of Mean Arterial Pressure, and Either End-tidal Anesthetic Concentration or Bispectral Index.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ability to Influence Behavior
Information Systems
Keywords: Intraoperative Monitoring
Decision Support Systems
anesthesia outcomes
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 20237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients presenting for general anesthesia and have BIS monitors

Exclusion Criteria:

* patients who opt out of the study

Primary outcomes:
measure: Mortality
timeFrame: at 90 days
Secondary outcomes:
measure: Response to Notification
timeFrame: Intraoperative
measure: Effect of response
timeFrame: Intraoperative
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Reich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCormick PJ, Levin MA, Lin HM, Sessler DI, Reich DL. Effectiveness of an Electronic Alert for Hypotension and Low Bispectral Index on 90-day Postoperative Mortality: A Prospective, Randomized Trial. Anesthesiology. 2016 Dec;125(6):1113-1120. doi: 10.1097/ALN.0000000000001296.