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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03656757
Other study ID # 2017/767
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2019
Est. completion date March 13, 2019

Study information

Verified date March 2019
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will assess the amount of energy that the heart will deliver to the central circulation and the efficiency of that energy transfer, in patients undergoing a coronary artery bypass graft operation. Measurements will be taken just after induction of anaesthesia and repeated just after the end of the operation. The total energy delivered by the heart will be calculated by multiplying a pressure curve from the artery in the hand with the instantaneous ultrasound recorded cardiac output flow curve. The energy responsible for the acceleration of the blood volume, known as oscillatory power will also be calculated. The energy transfer will be calculated using a mathematical model based upon other ultrasound and blood pressure recorded variables. We would like to see if any alteration in energy delivered is in part due to impairment in energy transfer or alteration of fraction of oscillatory power rather than a change in total energy production. We would also like to study if there are changes in the oscillatory power after cardiac bypass surgery. The patients will be sampled sequentially into the study. We are not aware of any such studies undertaken in humans previously.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date March 13, 2019
Est. primary completion date March 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective Coronary Artery Bypass Graft patients

- No contraindications to transoesophageal Echo

- Ejection fraction 40% or over

Exclusion Criteria:

- Lack of consent

- Emergency operation

- Prosthetic aortic valve

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway St Olavs Hospital 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 Arterioventricular coupling The ratio between arterial elastance and ventricular elastance 1 day
Primary Total Cardiac Power The amount of energy per second delivered from the left ventricle to the arterial circulation 1 day
Primary Oscillatory Cardiac Power The part of total cardiac power which is responsible for acceleration of the blood volume during systole. 1 day
Secondary Cardiac Output The hearts delivery of volume per minute 1 day
Secondary Heart rate The amount of heart beats per minute 1 day
Secondary Systemic vascular resistance The resistance to flow of the arterial tree 1 day
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