CardiomeDIC: Digital Image Correlation in Right Ventricular Evaluation

Sponsor

Tampere University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03115294

Collaborator

Tampere University of Technology (Other)

Enrollment

Location

Arm

41.2

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Ventricles	Drug: Theophylline Procedure: Ventilator positive end expiratory pressure adjustment Device: Videorecording	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Device Feasibility

Official Title:

Digital Image Correlation in Right Ventricular Evaluation in Cardiac Surgery

Actual Study Start Date :

May 16, 2016

Actual Primary Completion Date :

Oct 21, 2019

Actual Study Completion Date :

Oct 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning	Drug: Theophylline iv injection Procedure: Ventilator positive end expiratory pressure adjustment Positive end-expiratory pressure variation Device: Videorecording Myocardial movement videorecording

Arm

Intervention/Treatment

Experimental: Study group

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

Drug: Theophylline

iv injection

Procedure: Ventilator positive end expiratory pressure adjustment

Positive end-expiratory pressure variation

Device: Videorecording

Myocardial movement videorecording

Outcome Measures

Primary Outcome Measures

Heart ventricle function [Within the operation]
Changes in heart ventricle contraction status

Other Outcome Measures

ECG [Within the operation]
Simultaneous ECG recording and analysis during outcome 4 measurements
Transesophageal ultrasound [Within the operation]
Myocardial contraction range during video-clip
Cardiac output [Within the operation]
Measurement of cardiac output

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital, Heart Center	Tampere		Finland	33521

Sponsors and Collaborators

Tampere University Hospital
Tampere University of Technology

Investigators

Principal Investigator: Jari Laurikka, MD,PhD, Professor, Cardio-thoracic Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jari Laurikka, Professor, Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT03115294

Other Study ID Numbers:

R16045

First Posted:

Apr 14, 2017

Last Update Posted:

Dec 8, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Theophylline

Study Results

No Results Posted as of Dec 8, 2021