Digital Image Correlation in Right Ventricular Evaluation

Heart Ventricles Clinical Trial

— CardiomeDIC  

Official title:

Digital Image Correlation in Right Ventricular Evaluation in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115294
• Other study ID #: R16045
• Status: Completed
• Phase: N/A
• Start date: May 16, 2016
• Est. completion date: October 21, 2019

Study information

• Verified date: November 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings.

Description:

Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings. Right heart volume status and function is controlled and induced with theophylline and ventilator regulated positive end-expiratory pressure recordings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• open heart surgery, patient acceptance and informed consent, age 75 or more

Exclusion Criteria:

• patient refusal, psychiatric disorder or intoxication, irrepairable coronary artery disease, epilepsy or active neurological condition, active tbc or other contagious infection.

Related Conditions & MeSH terms

• Heart Ventricles

Intervention

Drug:
• Theophylline
iv injection

Procedure:
• Ventilator positive end expiratory pressure adjustment
Positive end-expiratory pressure variation

Device:
• Videorecording
Myocardial movement videorecording

Locations

Country	Name	City	State
Finland	Tampere University Hospital, Heart Center	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University of Technology

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Soltani A, Lahti J, Järvelä K, Curtze S, Laurikka J, Hokka M, Kuokkala VT. An Optical Method for the In-Vivo Characterization of the Biomechanical Response of the Right Ventricle. Sci Rep. 2018 May 1;8(1):6831. doi: 10.1038/s41598-018-25223-z. — View Citation

Soltani A, Lahti J, Järvelä K, Laurikka J, Kuokkala VT, Hokka M. Characterization of the anisotropic deformation of the right ventricle during open heart surgery. Comput Methods Biomech Biomed Engin. 2020 Feb;23(3):103-113. doi: 10.1080/10255842.2019.1703 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ECG	Simultaneous ECG recording and analysis during outcome 4 measurements	Within the operation
Other	Transesophageal ultrasound	Myocardial contraction range during video-clip	Within the operation
Other	Cardiac output	Measurement of cardiac output	Within the operation
Primary	Heart ventricle function	Changes in heart ventricle contraction status	Within the operation