Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery

Feasibility Clinical Trial

Official title:

Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012919
• Other study ID #: 1967/2014
• Status: Completed
• Phase: N/A
• First received: December 30, 2016
• Last updated: June 17, 2017
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rivers et al. laid the foundation for modern hemodynamic and fluid management by establishing goal directed therapy (GDT) for the treatment of sepsis using fluid and inotropic and vasoactive agents. There have been many subsequent protocols to improve outcome in the operating room or in the ICU. These are mainly passive decision support systems. Active clinical decision support systems using fluid and pharmacologic agents to improve intraoperative hemodynamics are not really found.

The investigators developed an active clinical decision support system based on an institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid device.

The goal of the study was to check the feasibility of an active clinical decision support system to optimize hemodynamics during high risk vascular surgery based on the principles of GDT implementing fluid, vasopressors and inotropes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective major vascular surgery such as peripheral arterial surgery and open abdominal aortic surgery except for carotid artery surgery

Exclusion Criteria:

• patients under 18 years of age

• absence of cardiac sinus rhythm at induction of anesthesia

Related Conditions & MeSH terms

• Active Decision Support System
• Feasibility
• Goal Directed Therapy

Intervention

Other:
• active decision support system
The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

References & Publications (4)

Feldheiser A, Conroy P, Bonomo T, Cox B, Garces TR, Spies C; Anaesthesia Working Group of the Enhanced Recovery After Surgery (ERAS®) Society; Enhanced Recovery After Surgery Society. Development and feasibility study of an algorithm for intraoperative goaldirected haemodynamic management in noncardiac surgery. J Int Med Res. 2012;40(4):1227-41. — View Citation

Fitzgerald M, Cameron P, Mackenzie C, Farrow N, Scicluna P, Gocentas R, Bystrzycki A, Lee G, O'Reilly G, Andrianopoulos N, Dziukas L, Cooper DJ, Silvers A, Mori A, Murray A, Smith S, Xiao Y, Stub D, McDermott FT, Rosenfeld JV. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011 Feb;146(2):218-25. doi: 10.1001/archsurg.2010.333. — View Citation

Sahota N, Lloyd R, Ramakrishna A, Mackay JA, Prorok JC, Weise-Kelly L, Navarro T, Wilczynski NL, Haynes RB; CCDSS Systematic Review Team. Computerized clinical decision support systems for acute care management: a decision-maker-researcher partnership systematic review of effects on process of care and patient outcomes. Implement Sci. 2011 Aug 3;6:91. doi: 10.1186/1748-5908-6-91. Review. — View Citation

Sondergaard S, Wall P, Cocks K, Parkin WG, Leaning MS. High concordance between expert anaesthetists' actions and advice of decision support system in achieving oxygen delivery targets in high-risk surgery patients. Br J Anaesth. 2012 Jun;108(6):966-72. doi: 10.1093/bja/aes037. Epub 2012 Mar 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of interventions done according to the active decision support system (GDT protocol)	The number of interventions done according to the active decision support system (GDT protocol) is calculated.	through study completion, an average of 6 months
Primary	duration of use of active decision support system	The absolute duration of use and relative duration of use (in relation to the duration of surgery) of the active decision support system are calculated.	through study completion, an average of 6 months