Ultrapower; a Minimally Invasive Tool for Evaluation of Total Cardiac Power

Cardiac Diseases Clinical Trial

Official title:

Ultrapower, an In-house Developed System for Instantaneous Logging of Ultrasound Based Blood Flow, Blood Pressure and ECG.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727634
• Other study ID #: 2016/49
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The heart is essentially a hydraulic pump which ensures adequate delivery of blood through generating pressure and forward flow of blood. The energy delivered by the heart is uncommonly measured clinically, and todays gold standard involves placing a plastic catheter into the lung arteries. The investigators have developed an ultrasound based approach to calculate this energy without the need for catheters through the heart. This novel approach is called ultrapower. Ultrapower involves the instantaneous multiplication of the cardiac output and the arterial blood pressure. The study aims to use the ultrasound based approach to investigate Cardiac Power in the coronary artery bypass graft population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• coronary artery bypass graft operation

Exclusion Criteria:

• Lack of informed consent

• Previous aortic valve replacement

• Inadequate Doppler signal on transthoracic echocardiography

Related Conditions & MeSH terms

• Cardiac Diseases
• Heart Diseases

Intervention

Other:
• Comparison cardiac power and cardiac power output at different time points in the perioperative period
The intervention is a comparison between two methods of calculating the heart's energy delivery, cardiac power, measured in watts. A tertiary measurement is calculation of arterioventricular coupling. All patients will have cardiac power output calculated through the use of Doppler echocardiography. The echocardiography based cardiac output will be done through the velocity time integral of the left ventricular outflow tract (LVOT). This will be compared against total power as measured by our Ultrapower approach which involves instantaneous doppler measurement of cardiac output through LVOT multiplied with simultaneous radial artery pressure. This and ejection fraction (for calculation of ventriculoarterial coupling) will be recorded at rest in neutral position preoperatively, directly post operatively and the day after operation. Directly postoperatively the power measurements will also be repeated in Trendelenburg and anti Trendelenburg position.

Locations

Country	Name	City	State
Norway	Department of cardiothoracic surgery	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method	Measured both as ultrapower and cardiac power output, both measured in watts and method of measurement described in intervention section	Immediately preoperatively
Primary	The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method		approximately 1 hour post operatively
Primary	The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method		1 day after operation