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
Recruitment status was Recruiting
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. Secondary outcomes will be the fraction of alerts that generate early clinician responses and the consequent increase in MAP.
Low Bispectral Index
Low Mean Arterial Blood Pressure
Low End-tidal Anesthetic Concentration
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official 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|
- reaction time [ Time Frame: 90-day ] [ Designated as safety issue: No ]Alert will prompt staff to enact quicker hemodynamic support, thus reduction in mortality
- Mean Arterial Pressure (MAP) [ Time Frame: intra-operative ] [ Designated as safety issue: No ]Alert will prompt staff to offer quicker hemodynamic support and increase of Mean Arterial Pressure (MAP).
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
The combination of low MAC, low MAP, and low BIS is thus a "Triple Low", which will set alerts by the Decision-Support System (DSS) .
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998894
|Contact: Gretchen A Upton, BAfirstname.lastname@example.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Daniel I Sessler, M.D.||The Cleveland Clinic|
|Study Director:||Wolf Stapelfeldt, MD||The Cleveland Clinic|