Randomized Trial of Alerts in Patients Demonstrating a "Triple Low"

A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a "Triple Low" of Mean-arterial Pressure, End-tidal Anesthetic Concentration, and Bispectral Index

The investigators propose to test the theory that smart alarms for the Triple Low State incorporated into a decision support system built into an electronic anesthesia record will prompt clinicians to intervene earlier in situations that would otherwise provoke little concern, and that the alert system will reduce 90-day mortality. Specifically, the investigators will test the hypothesis that providing Triple Low alerts reduces 90-day mortality.

Study Overview

• Status: Completed
• Conditions: Low Bispectral Index; Low Mean Arterial Blood Pressure; Low End-tidal Anesthetic Concentration

• Study Type: Observational
• Enrollment (Actual): 9846

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

adults presenting for non-cardiac surgery under volatile general anesthesia

Description

Inclusion Criteria:

• Adults presenting for non-cardiac surgery under volatile general anesthesia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
decision-support alerts; In patients experiencing a Triple Low (a combination of low MAC, low MAP, and low BIS), a warning alert will be generated for clinicians.
routine practice; In patients experiencing a Triple Low (a combination of low MAC, low MAP, and low BIS), a warning alert will not be generated for clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
90-day mortality	90-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality		30-days
Response to alerts	Vasopressor administration within 5 minutes or reduction in volatile anesthetic within 15 minutes of Triple Low onset	Intraoperative
Hospital-free days within the initial postoperative month		30-days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Daniel I Sessler, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: October 20, 2009
• First Posted (Estimate): October 21, 2009

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: MAP; MAC; BIS
• Other Study ID Numbers: 09-453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO