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CompletedNCT00998894Updated Mar 21, 2017

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

An observational study in Low Bispectral Index, Low Mean Arterial Blood Pressure and Low End-tidal Anesthetic Concentration, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-21.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9,846
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • BIS
  • MAC
  • MAP
03

In context

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adults presenting for non-cardiac surgery under volatile general anesthesia

Eligibility criteria

Inclusion Criteria:

  • Adults presenting for non-cardiac surgery under volatile general anesthesia
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9,846 participants (actual)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 90-day mortality

    Time frame: 90-days

Secondary outcomes

  1. 30-day mortality

    Time frame: 30-days

  2. Response to alerts

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

    Time frame: Intraoperative

  3. Hospital-free days within the initial postoperative month

    Time frame: 30-days

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00998894
Lead sponsor
The Cleveland Clinic
Responsible party
d sessler (Professor & Chair, The Cleveland Clinic) — Principal investigator
First posted
Oct 21, 2009
Start date
Oct 2009
Primary completion
Sep 2016
Completion
Dec 2016
Last update
Mar 21, 2017

Study contacts

Daniel I Sessler, M.D.
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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