Randomized Trial of Alerts in Patients Demonstrating a "Triple Low"
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|