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

NCT ID: NCT00998894

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9846 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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d sessler

Professor & Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel I Sessler, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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09-453

Identifier Type: -

Identifier Source: org_study_id

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