Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Summary

Conditions
Coronary (Artery) Disease
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 40 years and 80 years
Gender
Both males and females

Description

The purpose of the study is determine if there is a relationship between pre-operative vascular characteristics including, carotid-femoral pulse wave velocity (cfPWV), Augmentation Index(AI) and central aortic pressure, and the development of a pressure gradient between the aorta and radial artery a...

The purpose of the study is determine if there is a relationship between pre-operative vascular characteristics including, carotid-femoral pulse wave velocity (cfPWV), Augmentation Index(AI) and central aortic pressure, and the development of a pressure gradient between the aorta and radial artery after cardiopulmonary bypass. The procedures necessary to achieve the desired outcomes are as follows. The first measurement made by the research team will be pre-operative cardiac output (CO) measurement. The ICON device is a non-invasive device that measures CO, or the amount of blood that your heart pumps per minute. This device utilizes four stickers that are attached to skin, two on the left side of the neck and two located on the left side of the chest. These stickers function similarly to electrocardiogram (EKG) stickers that measure the electrical activity of your heart. After attachment of the stickers, the ICON device will be used to make a measurement of CO, which takes 1-2 minutes. After the measurement, the stickers will be removed and the ICON device will not be used again in the study. Secondly, pre-operative cfPWV, AI, and central aortic pressure measurements will be made. The Sphygmocor device will be utilized to make the pre-operative cfPWV, AI and central aortic pressure measurements. First, the AI measurements will be made using a non-invasive blood pressure cuff placed on the right arm. The patient's blood pressure will be measured twice in a row with this special blood pressure cuff. The blood pressure cuff on the right arm will be removed and then a cuff will be placed around the right thigh. Measurements will be made with a paper ruler from the patient's neck to the cuff on their leg. To make the cfPWV measurements, the cuff on the thigh will inflate while a pressure probe will be placed on the skin of the patient's right neck. Four measurements of cfPWV will be made with this technique. The intraoperative central aortic pressure measurement will be accomplished with the help of the cardiothoracic surgeon. The surgeon will place a catheter in the aorta as part of the coronary artery bypass grafting surgery. This catheter will be connected to the artificial heart-lung machine. Prior to turning on the heart-lung machine, the pressure in the aorta will be measured with this catheter. This is the standard of care for this type of surgery and will not delay the surgery. After the artificial heart-lung machine is turned off but before the catheter is removed from the aorta, the pressure will once again be measured. In order to measure intraoperative CO values, we will utilize the pulmonary artery (PA) catheter that was placed at the beginning of the surgery.. The patient will have a catheter placed in the right side of the neck that will travel through the heart and into a branch of the artery that goes from the heart to the lungs. This catheter will have the ability to measure the amount of blood that is pumped from the heart per minute. At the same times that the pressure in the aorta is measured (as above), the amount of blood that is pumped from the heart per minute will be measured. Lastly measurement of peripheral artery blood pressure will be accomplished with a right radial arterial catheter. Prior to the start of surgery, the patient will receive a special catheter in the radial artery of their right arm. This is the standard of care for blood pressure monitoring in this type of surgery. At the same times during the surgery that the pressure is being measured from the aortic catheter, the pressure will be measured from the catheter in the right radial artery.

Tracking Information

NCT #
NCT03142815
Collaborators
Not Provided
Investigators
Principal Investigator: Kenichi Ueda, MD, PhD University of Iowa Department of Anesthesia