Randomized Trial of Alerts in Patients Demonstrating a "Triple Low"
|ClinicalTrials.gov Identifier: NCT00998894|
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : March 21, 2017
|Condition or disease|
|Low Bispectral Index Low Mean Arterial Blood Pressure Low End-tidal Anesthetic Concentration|
|Study Type :||Observational|
|Actual Enrollment :||9846 participants|
|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|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||December 2016|
In patients experiencing a Triple Low (a combination of low MAC, low MAP, and low BIS), a warning alert will be generated for clinicians.
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.
- 90-day mortality [ Time Frame: 90-days ]
- 30-day mortality [ Time Frame: 30-days ]
- Response to alerts [ Time Frame: 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 [ Time Frame: 30-days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998894
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Daniel I Sessler, M.D.||The Cleveland Clinic|