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

Ability to Influence Behavior Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545596
• Other study ID #: GCO 10-0111
• Secondary ID: HSM 11-00590
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: May 23, 2014
• Start date: January 2011
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20237
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients presenting for general anesthesia and have BIS monitors

Exclusion Criteria:

• patients who opt out of the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ability to Influence Behavior
• Information Systems

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		at 90 days	No
Secondary	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	No
Secondary	Effect of response	An evaluation as to whether the response elicited resulted in less double low physiology	Intraoperative	No