Will a Real Time Advisory for Double Low State Change Clinical Behavior and Impact Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01545596
First received: March 1, 2012
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

The objective of this study is to use a decision-support system combined with an electronic anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) < 75 mmHg, and Bispectral Index (BIS) < 45) and generate alerts suggesting hemodynamic support. Specifically, the project will test the hypothesis that providing Double Low alerts reduces 90-day mortality. Secondary outcomes will be the fraction of alerts that generate early clinician responses, subsequent changes in MAP and hospital length of stay.


Condition Intervention
Ability to Influence Behavior
Information Systems
Behavioral: Notification through anesthesia system
Behavioral: No notification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Double and Triple Low Combination of Mean Arterial Pressure, and Either End-tidal Anesthetic Concentration or Bispectral Index.

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Mortality [ Time Frame: at 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to Notification [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    proportion of anesthesia teams that respond to a double low event with either a vasopressor or decrease in the dose of volatile anesthetic

  • Effect of response [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    An evaluation as to whether the response elicited resulted in less double low physiology


Estimated Enrollment: 14422
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Notification Group
Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.
Behavioral: Notification through anesthesia system
Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.
No Intervention: No Notification
No additional notification given to anesthesia team apart from the information on their monitors.
Behavioral: No notification
Anesthesia staff have access to all the information from the monitors, but the monitor does not analyze the data and send out announcements when double low events occur.

Detailed Description:

Data that is routinely collected as part of standard of care intraoperative monitoring including blood pressure, amount of anesthetic administered and a form of processes electroencephalogram called the bispectral index, which is a measure of depth of anesthesia all enter in an electronic record keeper. This project monitors for a combination of a blood pressure below mean of 75mmHg and a BIS of 45. When this is detected, half of the anesthesiologists caring for patients receive a text message on the computer screen and their pagers indicating that a double low situation exists and that they should consider intervening. The other half of practitioners are not provided with the additional messages, although all of the same information is available in the operating room (OR). Most patients undergoing general non-cardiac anesthesia at Mount Sinai are eligible. Documentation of consent was waived. All patients are informed of the ongoing project upon admission and are given a variety of methods of opting out of the project.

The analysis seeks to determine if the messages were effective at influencing clinician behavior and whether that change would make a difference in either length of stay or 90 day mortality.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients presenting for general anesthesia and have BIS monitors

Exclusion Criteria:

  • patients who opt out of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545596

Contacts
Contact: Dionne Bobb 212-241-7749 dionne.bobb@mssm.edu

Locations
United States, New York
Mount Sinai School of Medicine / Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Dionne Bobb    212-241-7749    dionne.bobb@mssm.edu   
Contact: Jeffrey Silverstein, MD       jeff.silverstein@mssm.edu   
Principal Investigator: David Reich, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: David Reich, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01545596     History of Changes
Other Study ID Numbers: GCO 10-0111, HSM 11-00590
Study First Received: March 1, 2012
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Intraoperative Monitoring
Decision Support Systems
anesthesia outcomes

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 April 17, 2014