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OpenTrials
Completed

NCT Number: NCT01545596

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients presenting for general anesthesia and have BIS monitors

Exclusion criteria

  • patients who opt out of the study

Treatment and study plan

Notification Group

Behavioral

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

Other names: Notification through anesthesia system

Primary outcomes

  1. Mortality

    Time frame: at 90 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2012
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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