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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00998894

Enrollment

9846

Registered

2009-10-21

Start date

2009-10-31

Completion date

2016-12-31

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Bispectral Index, Low End-tidal Anesthetic Concentration, Low Mean Arterial Blood Pressure

Keywords

BIS, MAC, MAP

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
90-day mortality	90-days

Secondary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results