Health Condition 1: Q24- Other congenital malformations ofheart
Conditions
Interventions
Intervention1: HeartOs in Healthy subjects: 50 apparently healthy subjects (pediatric and adult ) more than 6 months of age with no known underlying cardiovascular disorders or medical conditions to
Sponsors
Fourth Frontier Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: o Subjects admitted to inpatient for a scheduled corrective surgical or percutaneous intervention or subjects sent for a cardiac check-up in the OPD/Clinic. o Age: > 6 months of age of both genders. o Pediatric/Adult Subjects with a known diagnosis of CHD (including ASD, VSD, PDA, TOF and Congenital Structural Valve Defects (including patients with Pulmonic and Aortic stenosis scheduled for Balloon Dilatation) as diagnosed by a physician either clinically or by means of a diagnostic device to form the study group. o Pediatric/Adult patients without any underlying cardiac disorders/ medical conditions and cleared to be healthy by qualified medical personnel to form the control group that will be matched for both age and gender with the study group. o Informed Consent as documented by the signature (Appendix: Assent Form (FOR CHILDREN 7 to < 18 years of age & Informed Consent Form).
Exclusion criteria
Exclusion criteria: o Subjects o Subjects with a critical underlying cardiac problem, or obstructive left-sided heart lesions. o Subjects on a ventilator or any other kind of life support system. o Subjects assessed to be in a serious or life-threatening situation due to any cause e.g. significant concomitant disease states (e.g., renal failure, major neurological deficits, hepatic dysfunction, etc.). o Known or suspected non-compliance, drug or alcohol abuse. o Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of a method for non-invasive monitoring, that can provide a personalized understanding of how the cardiac parameters such as Electrocardiogram (ECG), Heart Rate (HR), Pre-ejection Period (PEP), Left- ventricular ejection time (LVET), vary prior to and after therapeutic interventions.Timepoint: - Once immediately/24-48 hours prior to therapeutic intervention, - Once immediately or 48-72 hrs post-intervention or prior to discharge and - 3 months post intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Validate Respiratory rate (RR) obtained by the device in comparison with manual / auscultatory method by a qualified medical personnel - Draw a comparison (increase/decrease) of the pre and post intervention STIs ( PEP, LVET and PEP/LVET ratio) derived from the HeartOs and the 2D Echocardiography in the study group of patients (medically diagnosed with CHD) - Compare STIs from patients in study group (with CHD) with control group (healthy) matched for age, gender.Timepoint: - Once immediately/24-48 hours prior to therapeutic intervention, - Once immediately or 48-72 hrs post-intervention or prior to discharge and - 3 months post intervention. | — |
Countries
India
Contacts
Public ContactDr Reeta Varyani
Sri Sathya Sai Institute of Higher Medical Sciences (SSSIHMS)
Outcome results
None listed