Evaluation of Drug Display in Critical Care Setting

August 8, 2016 updated by: Noah Syroid, University of Utah
To assess the clinical utility of the graphical medication monitor, results of the anesthetics for which the display was present will be compared to the results of the anesthetics in which there was no display.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study has two objectives: First, before the medication monitor is shown to anesthesiologists in a clinical setting, the PKPD models must be validated to assess the clinical reliability of the model-based predictions for patients undergoing general anesthesia. Second, once the PKPD models have been successfully validated, presenting it to anesthesiologists during administration of anesthesia will assess the impact of the graphical medication monitor. Differences in performance and patient care will be determined by comparing anesthesiologists who are presented with the monitor to those who care for patients without the monitor.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents

Description

Inclusion Criteria:

  • Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents and have been trained on the graphic display

Exclusion Criteria:

  • Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents that have not been trained on the graphic display

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
For the phase of the study in which the utility of the graphical medication monitor is assessed, the monitor will not be shown to anesthesiologists placed in the control condition.
2
In the experimental condition, anesthesiologists will be shown the medication monitor to aid their expertise and decision-making.
Device: medication monitor
the medication monitor will aid in expertise and decision-making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
assess differences between medication administration data and patient information with and without the use of the graphical medication monitor.
Time Frame: preoperative, intraoperative and postoperative
preoperative, intraoperative and postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Ken Johnson, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (ESTIMATE)

July 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10599 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • 1R43GM066615-01A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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