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OpenTrials
Completed

NCT Number: NCT00998894

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 90-day mortality

    Time frame: 90-days

Secondary outcomes

  1. 30-day mortality

    Time frame: 30-days

  2. Response to alerts

    Time frame: Intraoperative

    Vasopressor administration within 5 minutes or reduction in volatile anesthetic within 15 minutes of Triple Low onset

  3. Hospital-free days within the initial postoperative month

    Time frame: 30-days

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2009
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.