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Completed

NCT Number: NCT02727634

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

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.

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Key information

Conditions

Cardiac Diseases Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of cardiothoracic surgery

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • coronary artery bypass graft operation

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method

    Time frame: Immediately preoperatively

    Measured both as ultrapower and cardiac power output, both measured in watts and method of measurement described in intervention section

  2. The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method

    Time frame: approximately 1 hour post operatively

  3. The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method

    Time frame: 1 day after operation

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2016
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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