NCT01545596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

3.3 years

First QC Date

March 1, 2012

Last Update Submit

May 23, 2014

Conditions

Ability to Influence BehaviorInformation Systems

Keywords

Intraoperative MonitoringDecision Support Systemsanesthesia outcomes

Outcome Measures

Primary Outcomes (1)

  • Mortality

    at 90 days

Secondary Outcomes (2)

  • Response to Notification

    Intraoperative

  • Effect of response

    Intraoperative

Study Arms (2)

Notification Group

EXPERIMENTAL

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

Behavioral: Notification Group

No Notification

NO INTERVENTION

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

Interventions

Notification GroupBEHAVIORAL

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

Also known as: Notification through anesthesia system
Notification Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting for general anesthesia and have BIS monitors

You may not qualify if:

  • patients who opt out of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

    PMID: 27775995DERIVED

Study Officials

  • David Reich, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

January 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

US(1)