NCT06090396

Non-invasive Cardiac Index in Children

Non-invasive Cardiac Index Monitoring in Young Children During the Perioperative Period: Quantitative Comparison of Electrical Cardiometry and Transthoracic Echocardiography

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Laszlo Vutskits · Academic / Other
• Sex: All
• Age: 0 Months – 17 Months
• Healthy volunteers: —

Summary

This study investigates the level of agreement of two non-invasive cardiac output monitors (transthoracic echocardiography and electrical cardiometry) in young children under anesthesia.

Detailed description

Young children are particularly prone to hemodynamic instability during the perioperative period which, in turn, may lead to organ morbidity. Currently, in routine surgical procedures in otherwise healthy children, hemodynamic status in the perioperative period is primarily assessed by non-invasive systemic blood pressure management. While this approach can detect systemic arterial hypotension, it does not provide us with guidance on whether the decrease in blood pressure is the result of changes in cardiac output and/or in systemic vascular resistance. This information would be important to know since treatment modalities may differ. Recent technical development in electrical cardiometry allows us to non-invasively monitor cardiac output. The accuracy of the method has been validated in neonatal and paediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. Nevertheless, the trending patterns of cardiac output in otherwise healthy young children undergoing routine surgical procedures, still need to be described. Due to technical aspects, transthoracic echocardiography is now recognised as "gold-standard" measurement of cardiac output in paediatric patients. This study is based on a commonly and non-invasively applied monitoring equipment (ICON) which is now regularly used on anesthetized children for the detection of cardiac output during the perioperative period. The primary objective of this validation study is to confirm the non-inferiority of cardiac output measurement with electrical cardiometry versus transthoracic echocardiography in young children ( 0-17 months of age) during the perioperative period. The secondary objective is to describe the trending aspects of cardiac output during the anaesthesia until the recovery.

Conditions

• Cardiac Output
• Anesthesia
• Infant ALL

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cardiac output monitoring with electrical cardiometry	comparison of limits of agreement between the two monitoring modalities

Timeline

• Start date: 2023-10-15
• Primary completion: 2025-10-10
• Completion: 2025-12-10
• First posted: 2023-10-19
• Last updated: 2023-12-05

Locations

1 site across 1 country: Switzerland