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

Not Applicable

Completed

• Conditions: Ability to Influence Behavior; Information Systems
• Interventions: Behavioral: Notification Group

• Registration Number: NCT01545596
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-23
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20237

Inclusion Criteria

• All patients presenting for general anesthesia and have BIS monitors

Exclusion Criteria

• patients who opt out of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Notification Group	Notification Group	Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.

Primary Outcome Measures

Name	Time	Method
Mortality	at 90 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States