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

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.

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 Overview

• Status: Completed
• Conditions: Ability to Influence Behavior; Information Systems
• Intervention / Treatment: Behavioral: Notification Group

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.

• Study Type: Interventional
• Enrollment (Actual): 20237
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients presenting for general anesthesia and have BIS monitors

Exclusion Criteria:

• patients who opt out of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: David Reich, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 23, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Intraoperative Monitoring; Decision Support Systems; anesthesia outcomes
• Other Study ID Numbers: GCO 10-0111; HSM 11-00590