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Digital Image Correlation in Right Ventricular Evaluation

NCT ID: NCT03115294

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-16

Study Completion Date

2019-10-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Ventricles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DEVICE_FEASIBILITY

Blinding Strategy

NONE

video analysts do not get information of the clinical data or procedure phase

Study Groups

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Study group

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

Group Type EXPERIMENTAL

Theophylline

Intervention Type DRUG

iv injection

Ventilator positive end expiratory pressure adjustment

Intervention Type PROCEDURE

Positive end-expiratory pressure variation

Videorecording

Intervention Type DEVICE

Myocardial movement videorecording

Interventions

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Theophylline

iv injection

Intervention Type DRUG

Ventilator positive end expiratory pressure adjustment

Positive end-expiratory pressure variation

Intervention Type PROCEDURE

Videorecording

Myocardial movement videorecording

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University of Technology

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jari Laurikka

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jari Laurikka, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Cardio-thoracic Surgery

Locations

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Tampere University Hospital, Heart Center

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type RESULT
PMID: 31847587 (View on PubMed)

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.

Reference Type RESULT
PMID: 29717224 (View on PubMed)

Other Identifiers

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R16045

Identifier Type: -

Identifier Source: org_study_id