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

NCT02727634 | Completed

• 1 other identifier: 2016/49
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Diseases

Keywords

Hemodynamics; Echocardiography, Doppler, Pulsed

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (1)

Postoperative elective CABG patients

OTHER

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

Interventions

Comparison cardiac power and cardiac power output at different time points in the perioperative period OTHER

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.

Postoperative elective CABG patients

Eligibility Criteria

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

You may qualify if:

• coronary artery bypass graft operation

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Department of cardiothoracic surgery

Trondheim, Norway

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Idar Kirkeby-Garstad, md phd

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: April 4, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

NO (1)