Digital Image Correlation in Right Ventricular Evaluation

NCT03115294 | Completed

• 1 other identifier: R16045
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Ventricles

Outcome Measures

Primary Outcomes (1)

• Heart ventricle function

  Changes in heart ventricle contraction status

  Within the operation

Other Outcomes (3)

• ECG

  Within the operation

• Transesophageal ultrasound

  Within the operation

• Cardiac output

  Within the operation

Study Arms (1)

Study group

EXPERIMENTAL

Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning

Drug: Theophylline; Procedure: Ventilator positive end expiratory pressure adjustment; Device: Videorecording

Interventions

Theophylline DRUG

iv injection

Study group

Ventilator positive end expiratory pressure adjustment PROCEDURE

Positive end-expiratory pressure variation

Study group

Videorecording DEVICE

Myocardial movement videorecording

Study group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University of Technology: collaborator

Study Sites (1)

Tampere University Hospital, Heart Center

Tampere, 33521, Finland

Location

Related Publications (2)

• Soltani A, Lahti J, Jarvela 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: 10.1080/10255842.2019.1703133. Epub 2019 Dec 17.

  PMID: 31847587 RESULT

• Soltani A, Lahti J, Jarvela 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.

  PMID: 29717224 RESULT

MeSH Terms

Interventions

Theophylline

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jari Laurikka, MD,PhD

  Professor, Cardio-thoracic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: video analysts do not get information of the clinical data or procedure phase
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients undergo medication intervention (w/intravenous theophylline) and ventilator volume adjustements, and serial ventricular function parameters are compared (pre-and post-intervention measurements).

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: April 14, 2017
• Study Start: May 16, 2016
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)