Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
d sessler, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00998894
First received: October 19, 2009
Last updated: February 27, 2016
Last verified: February 2016
  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.

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 The Cleveland Clinic:

Primary Outcome Measures:
  • 90-day mortality [ Time Frame: 90-days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30-day mortality [ Time Frame: 30-days ] [ Designated as safety issue: No ]
  • Response to alerts [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 9846
Study Start Date: October 2009
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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: Roberta Johnson, BA 216-444-9950 johnsor13@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Daniel I Sessler, M.D. The Cleveland Clinic
  More Information

Responsible Party: d sessler, Professor & Chair, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00998894     History of Changes
Other Study ID Numbers: 09-453 
Study First Received: October 19, 2009
Last Updated: February 27, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
BIS
MAC
MAP

ClinicalTrials.gov processed this record on September 23, 2016