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

NCT ID: NCT01545596

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-05-31

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.

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.

Conditions

Ability to Influence Behavior; Information Systems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Notification Group

Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.

Group Type: EXPERIMENTAL

Notification Group

Intervention Type: BEHAVIORAL

Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.

No Notification

No additional notification given to anesthesia team apart from the information on their monitors.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Notification Group

Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.

Intervention Type: BEHAVIORAL

Other Intervention Names

Notification through anesthesia system

Eligibility Criteria

Inclusion Criteria

• All patients presenting for general anesthesia and have BIS monitors

Exclusion Criteria

• patients who opt out of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Reich, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

McCormick PJ, Levin MA, Lin HM, Sessler DI, Reich DL. Effectiveness of an Electronic Alert for Hypotension and Low Bispectral Index on 90-day Postoperative Mortality: A Prospective, Randomized Trial. Anesthesiology. 2016 Dec;125(6):1113-1120. doi: 10.1097/ALN.0000000000001296.

Reference Type: DERIVED

PMID: 27775995 (View on PubMed)

Other Identifiers

HSM 11-00590

Identifier Type: -

Identifier Source: secondary_id

GCO 10-0111

Identifier Type: -

Identifier Source: org_study_id