Evaluation of Drug Display in Critical Care Setting

Decision Making Clinical Trial

Official title:

Evaluation of Drug Display in Critical Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715507
• Other study ID #: 10599
• Secondary ID: 1R43GM066615-01A
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: August 8, 2016
• Start date: July 2003
• Est. completion date: August 2012

Study information

• Verified date: August 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Decision Making

Intervention

Device:
• medication monitor
the medication monitor will aid in expertise and decision-making.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess differences between medication administration data and patient information with and without the use of the graphical medication monitor.		preoperative, intraoperative and postoperative	No