Will a Real Time Advisory for Double Low State Change Clinical Behavior and Impact Outcomes
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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. |
- Mortality [ Time Frame: at 90 days ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- All patients presenting for general anesthesia and have BIS monitors
Exclusion Criteria:
- patients who opt out of the study
Contacts and Locations| Contact: Dionne Bobb | 212-241-7749 | dionne.bobb@mssm.edu |
| 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 | |
| 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 May 21, 2013