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

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ClinicalTrials.gov Identifier: NCT01545596
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
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 or disease Intervention/treatment Phase
Ability to Influence Behavior Information Systems Behavioral: Notification Group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : January 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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 Group
Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.
Other Name: Notification through anesthesia system
No Intervention: No Notification
No additional notification given to anesthesia team apart from the information on their monitors.



Primary Outcome Measures :
  1. Mortality [ Time Frame: at 90 days ]

Secondary Outcome Measures :
  1. Response to Notification [ Time Frame: Intraoperative ]
    proportion of anesthesia teams that respond to a double low event with either a vasopressor or decrease in the dose of volatile anesthetic

  2. Effect of response [ Time Frame: Intraoperative ]
    An evaluation as to whether the response elicited resulted in less double low physiology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT01545596


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: David Reich, MD Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01545596     History of Changes
Other Study ID Numbers: GCO 10-0111
HSM 11-00590
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs