Hemodynamic Survey Cardiac Surgical Scenarios

Low Cardiac Output Clinical Trial

Official title:

Comparative Hemodynamic Assessment Between Lidco Rapid and Pulmonary Artery Thermodilution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529033
• Other study ID #: 201504777
• Status: Completed
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac output) is as equivalent in determining the hemodynamic assessment in cardiac surgical scenarios as the most often used pulmonary artery catheter, which is much more invasive than the Lidco Rapid. This will be accomplished through online surveys which have different cardiac surgery scenarios and will be distributed to cardiac fellowship trained anesthesiologists. The online based survey will include a specific scenario and details on the scenario represented in image format and a brief description of the patient to aid with their analysis of the situation.

Description:

Data from PA catheter such as PA pressure, pulmonary wedge pressure and cardiac output has been widely used in the various clinical situations warranting advance hemodynamic monitoring. It is considered as gold standard but unfortunately there is always risk associated with PA catheter and time lag between the clinical events and interpretation. Lidco Rapid is one of the non-invasive hemodynamic tools to measure various parameters. It is widely used in the intensive care set up for goal directed therapy but unfortunately there is not enough data to show whether it is useful in various peri-operative clinical conditions. In the online based survey, responses from the participants are recorded in the nominal scale ( 1 to 5 where 3 represents near normal). This survey will help to determine whether Investigators can replace the Lidco in any clinical situation warranting advance hemodynamic monitoring. No previous study was done to specifically find out the hemodynamic component that differs between these tools intraoperatively in varying hemodynamic conditions during cardiac surgery although there were few studies compared the trend in the cardiac output with difference in opinion on their accuracy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must be a certified Anesthesiologist with cardiac fellowship training

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cardiac Output, Low
• Low Cardiac Output

Intervention

Device:
• LIDCO Rapid, Pulmonary artery catheter
Hemodynamic monitoring systems

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

References & Publications (2)

Broch O, Renner J, Hocker J, Gruenewald M, Meybohm P, Schottler J, Steinfath M, Bein B. Uncalibrated pulse power analysis fails to reliably measure cardiac output in patients undergoing coronary artery bypass surgery. Crit Care. 2011;15(1):R76. doi: 10.1186/cc10065. Epub 2011 Feb 28. — View Citation

Hadian M, Kim HK, Severyn DA, Pinsky MR. Cross-comparison of cardiac output trending accuracy of LiDCO, PiCCO, FloTrac and pulmonary artery catheters. Crit Care. 2010;14(6):R212. doi: 10.1186/cc9335. Epub 2010 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To expect difference is within 1 unit ( scale of 1 to 5) in the hemodynamic assessment preferably preload , afterload and contractility between Lidco and data from PA catheter in different cardiac surgical patient scenarios.		intraoperative