Will a Real Time Advisory for Double Low State Change Clinical Behavior and Impact Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Ability to Influence Behavior, Information Systems

Intervention / Treatment
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* Behavioral: Notification Group


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Notification Group<br>Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not. | Behavioral: Notification Group<br>* Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.<br>* Other names: Notification through anesthesia system;|
| No Intervention: No Notification<br>No additional notification given to anesthesia team apart from the information on their monitors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | at 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Notification | proportion of anesthesia teams that respond to a double low event with either a vasopressor or decrease in the dose of volatile anesthetic | Intraoperative | 
| Effect of response | An evaluation as to whether the response elicited resulted in less double low physiology | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative Monitoring, Decision Support Systems, anesthesia outcomes