Digital Image Correlation in Right Ventricular Evaluation

Not Applicable

Completed

• Conditions: Heart Ventricles
• Interventions: Drug: Theophylline; Procedure: Ventilator positive end expiratory pressure adjustment; Device: Videorecording

• Registration Number: NCT03115294
• Lead Sponsor: Tampere University Hospital

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.

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 Timeline

• Study Start: 2016-05-16
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Ventilator positive end expiratory pressure adjustment	Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning
Study group	Videorecording	Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning
Study group	Theophylline	Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning

Primary Outcome Measures

Name	Time	Method
Heart ventricle function	Within the operation	Changes in heart ventricle contraction status

Trial Locations

Locations (1)

Tampere University Hospital, Heart Center; 🇫🇮 Tampere, Finland