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

NCT03012919 | Completed

• 1 other identifier: 1967/2014
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Feasibility; Active Decision Support System; Goal Directed Therapy

Keywords

active decision support system; goal directed therapy; Lidco; vascular surgery; hemodynamic optimization

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

active decision support system (GDT protocol)

OTHER

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).

Other: active decision support system

Interventions

active decision support system OTHER

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).

Also known as: goal directed therapy (GDT) protocol

active decision support system (GDT protocol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients under 18 years of age
• absence of cardiac sinus rhythm at induction of anesthesia

Sponsors & Collaborators

• Medical University of Vienna: lead

Related Publications (4)

• 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.

  PMID: 21339436 BACKGROUND

• Feldheiser A, Conroy P, Bonomo T, Cox B, Garces TR, Spies C; Anaesthesia Working Group of the Enhanced Recovery After Surgery (ERAS(R)) 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. doi: 10.1177/147323001204000402.

  PMID: 22971475 BACKGROUND

• 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.

  PMID: 22427342 BACKGROUND

• 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.

  PMID: 21824385 BACKGROUND

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Martin Dworschak, Prof. Dr.

  Medical University of Vienna

  STUDY DIRECTOR

• Michael Hiesmayr, Prof. Dr.

  Medical University of Vienna

  STUDY DIRECTOR

• Johannes Menger, Dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Arabella Fischer, Dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 6, 2017
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 20, 2017

Record last verified: 2017-06