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

Completed

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

• Registration Number: NCT00998894
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9846

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-day mortality	90-days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States