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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Outcomes Research Consortium.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Daniel I. Sessler, M.D., Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00998894
First received: October 19, 2009
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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.


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

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • reaction time [ Time Frame: 90-day ] [ Designated as safety issue: No ]
    Alert will prompt staff to enact quicker hemodynamic support, thus reduction in mortality


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 9846
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)
Groups/Cohorts
decision-support alerts
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) .
routine practice
routine practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adults presenting for non-cardiac surgery under volatile general anesthesia

Criteria

Inclusion Criteria:

  • Adults presenting for non-cardiac surgery under volatile general anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998894

Contacts
Contact: Gretchen A Upton, BA 216-444-3289 uptong@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Daniel I Sessler, M.D. The Cleveland Clinic
Study Director: Wolf Stapelfeldt, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Daniel I. Sessler, M.D., Chairman, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT00998894     History of Changes
Other Study ID Numbers: 09-453
Study First Received: October 19, 2009
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
BIS
MAC
MAP

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014