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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02727634

Collaborator

St. Olavs Hospital (Other)

Enrollment

Location

Arm

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Diseases	Other: Comparison cardiac power and cardiac power output at different time points in the perioperative period	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Postoperative elective CABG patients Patients included for coronary artery bypass graft (CABG) surgery, secondary to ischaemic heart disease.	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.

Arm

Intervention/Treatment

Other: Postoperative elective CABG patients

Patients included for coronary artery bypass graft (CABG) surgery, secondary to ischaemic heart disease.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• coronary artery bypass graft operation

Exclusion Criteria:

Lack of informed consent
Previous aortic valve replacement
Inadequate Doppler signal on transthoracic echocardiography

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of cardiothoracic surgery	Trondheim		Norway

Sponsors and Collaborators

Norwegian University of Science and Technology
St. Olavs Hospital

Investigators

Principal Investigator: Idar Kirkeby-Garstad, md phd, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT02727634

Other Study ID Numbers:

2016/49

First Posted:

Apr 4, 2016

Last Update Posted:

Mar 27, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Norwegian University of Science and Technology

Hemodynamics

Echocardiography, Doppler, Pulsed

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of Mar 27, 2019