Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia

  • STATUS
    Recruiting
  • participants needed
    106
  • sponsor
    University Hospital Inselspital, Berne
Updated on 19 February 2024
strain
heart surgery
bypass graft
coronary artery disease
arterial disease
coronary artery bypass graft
cardiac operation

Summary

The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.

Description

Up to 106 patients with coronary artery disease undergoing elective coronary artery bypass graft (CABG) surgery will be recruited to undergo this single visit study. In the timeframe shortly after the induction of anaesthesia and prior to the start of surgery, myocardial strain as a marker of cardiac function will be measured by transesophageal echocardiography (TEE). Echocardiography measurements will be acquired at two different oxygen states for each patient. The fraction of inspired oxygen (FiO2) will be adjusted to reach a normoxaemic state (FiO2=0.3) and a hyperoxic state (FiO2=0.8). Patients will be randomized to which oxygen level is investigated first. Thereafter, the study intervention is completed and anaesthesia and surgery will be performed as planned by the treating team. Echocardiography images will be analyzed in a blinded manner for cardiac function and systolic and diastolic strain parameters. The results will help anaesthesiologists to better weigh risks and benefits when selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia as a risk factor for myocardial injury.

Details
Condition Coronary Artery Disease, Coronary Artery Disease, Coronary heart disease, Anesthesia, Anesthesia
Age 18-100 years
Treatment Oxygen
Clinical Study IdentifierNCT04424433
SponsorUniversity Hospital Inselspital, Berne
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Elective CABG surgery (with or without other cardiac surgery)
Ability to give and sign informed consent
Age >18 years

Exclusion Criteria

Absolute contraindication for TEE
Emergency surgery, including but not limited to patients with instable CAD: ST- and Non-ST-elevation myocardial infarction (STEMI, NSTEMI) and instable angina (instable AP)
Atrial fibrillation or significant arrhythmia
Pacemaker, CRT, left bundle branch block
Severe-grade valvular disease
Pericardial disease
Previous cardiac or thoracic aortic surgery
Previous chest radiation therapy or cardiotoxic or bleomycin chemotherapy
Severe pulmonary hypertension, cor-pulmonale, or right ventricular dysfunction, i.e., where high FIO2 might reduce pulmonary vascular resistance and right ventricular afterload
Patients where study explanation and informed consent cannot been performed/obtained at the latest on the day before scheduled surgery
Females of child-bearing potential
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.